Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- K250948TriMed Fusion Cup System2Cleared 510(K)
- K243995Arthrex Humeral Plating System and Cerclage Button2Cleared 510(K)
- K243999TriMed Ankle Fixation System2Cleared 510(K)
- K243987TriMed Elbow and Forearm System2Cleared 510(K)
- K242486Tyber Medical Anatomical Plating System2Cleared 510(K)
- K250494The OsteoCentric Bone Plate and Screw System2Cleared 510(K)
- K250498BPS Wrist Fracture System2Cleared 510(K)
- K243610APTUS Hand System; APTUS Elbow Dorsal Olecranon2Cleared 510(K)
- K243357CastleLoc Pectus Bar System2Cleared 510(K)
- K243761A.L.P.S. Small Fragment Plating System2Cleared 510(K)
- K241666EVOS Pelvic and Acetabular System2Cleared 510(K)
- K240958Locking Plates and Screws Systems2Cleared 510(K)
- K250055BPS - Bone Fragment Fixation Plates, Screws and Washers2Cleared 510(K)
- K241599Signature Osteosynthesis Plate System2Cleared 510(K)
- K243740Versalock Upper Limb Plating System2Cleared 510(K)
- K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);2Cleared 510(K)
- K242939ARTFX Trauma Bone Plate and Screw System2Cleared 510(K)
- K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)2Cleared 510(K)
- K243491SternalPlate Expansion2Cleared 510(K)
- K241128TDM Plate and Screw System2Cleared 510(K)
- K243050TriMed Posterior Malleolus Fixation System2Cleared 510(K)
- K241995HyperFlex™ Bunion Correction System2Cleared 510(K)
- K242998GMReis Ankle Plating System2Cleared 510(K)
- K242596Versalock Mini and Micro Plating System2Cleared 510(K)
- K242814Tandry Q-Locking Plate System2Cleared 510(K)
- K242436Proximal Humerus Fixation System2Cleared 510(K)
- K242079Arthrex Elbow Fracture Plating System2Cleared 510(K)
- K240388Osteotomy Truss System (OTS)2Cleared 510(K)
- K242399Bonebridge Osteosynthesis Plating System2Cleared 510(K)
- K242995OIC Small / Mini Fragment Plate System2Cleared 510(K)
- K242554Arthrex VAL and VAL KreuLock™ Compression Screw System2Cleared 510(K)
- K240181Clavicle and Scapula System2Cleared 510(K)
- K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System2Cleared 510(K)
- K242343BPS Wrist Fracture System2Cleared 510(K)
- K241815Protean Fragment Plating System2Cleared 510(K)
- K241709Pectus Blu Support Bar System2Cleared 510(K)
- K241942TriMed Bridge Plates2Cleared 510(K)
- K241356Fine Osteotomy™2Cleared 510(K)
- K240487EVOS Patella Plates2Cleared 510(K)
- K233816REDEMPTION Charcot Plating System2Cleared 510(K)
- K240318SITTER 3.5mm Versatile System2Cleared 510(K)
- K241282RibFix Titan™ Fixation System2Cleared 510(K)
- K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate2Cleared 510(K)
- K241387CoLink NeoFuse MIS Plating System (see attached parts list)2Cleared 510(K)
- K242055Freefix Forearm Plating System2Cleared 510(K)
- K241539Activmotion S2Cleared 510(K)
- K233994VOLT™ Proximal Humerus 3.5 Plating System2Cleared 510(K)
- K241296Gaudi Proximal Humerus Plate2Cleared 510(K)
- K241018KLS Martin Orthopedic Implants - MR Conditional2Cleared 510(K)
- K234059Forma Medical Optimal Plating System2Cleared 510(K)
- K232829Versalock Rib and Sternum Plates System2Cleared 510(K)
- K240613APTUS Elbow Dorsal Olecranon Plates2Cleared 510(K)
- K230546SIGNEX2Cleared 510(K)
- K241262Baby Gorilla/Gorilla Plating System; Monster Screw System2Cleared 510(K)
- K241218Tyber Medical Anatomical Plating System2Cleared 510(K)
- K233089NeoSpan® Compression Implant System2Cleared 510(K)
- K233967DePuy Synthes MatrixSTERNUM Fixation System2Cleared 510(K)
- K233873XLO Brand of Locking Distal Humerus Plating System2Cleared 510(K)
- K233311Acumed Wrist Plating System2Cleared 510(K)
- K232105APTUS Foot System 2.8-3.52Cleared 510(K)
- K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-2Cleared 510(K)
- K240703Fine Osteotomy™2Cleared 510(K)
- K232115TDM Large Bone Plate and Screw System2Cleared 510(K)
- K233919VariAx 2 Distal Radius System2Cleared 510(K)
- K234062APTUS Hand Scaphoid Plates2Cleared 510(K)
- K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System2Cleared 510(K)
- K240173Treace Medical Systems (TMC) Plating System2Cleared 510(K)
- K231213HKT Anatomical Locking Trauma System2Cleared 510(K)
- K234031Medline UNITE Ancillary Foot Recon Plating System2Cleared 510(K)
- K231684Quick - Radius Disposable Set2Cleared 510(K)
- K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System2Cleared 510(K)
- K233154SkyOPS™ Orthopedic Plate System2Cleared 510(K)
- K233017TM Plating System2Cleared 510(K)
- K232394Internal Locking Plate and Screw Fixation System2Cleared 510(K)
- K231887ARIX Ankle Distal Tibia System2Cleared 510(K)
- K232652Anatomical Plating System (various)2Cleared 510(K)
- K232515Valkyrie Thoracic Fixation System2Cleared 510(K)
- K232693Tyber Medical Distal Radius Plating System2Cleared 510(K)
- K230591TriLEAP Plating System2Cleared 510(K)
- K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws2Cleared 510(K)
- K230805TriMed Clavicle Fixation System2Cleared 510(K)
- K230623KITE Distal Fibula Kit2Cleared 510(K)
- K231623Distal Elbow Plating System2Cleared 510(K)
- K223150APS Metal Plate & Screw System2Cleared 510(K)
- K232144Sterile Products of the APTUS System2Cleared 510(K)
- K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System2Cleared 510(K)
- K231257Pangea Utility Plating System, Pangea Platform2Cleared 510(K)
- K230690Tandry Locking Plate System2Cleared 510(K)
- K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System2Cleared 510(K)
- K231441ARIX Ankle System2Cleared 510(K)
- K230971APTUS® 3.5 TriLock Straight Plates2Cleared 510(K)
- K223762Smith & Nephew ACCORD™ Cable System2Cleared 510(K)
- K222624KLS Martin LINOS Wrist System2Cleared 510(K)
- K230938ARIX Humerus System2Cleared 510(K)
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System2Cleared 510(K)
- K230204ALPHALOK Plating System2Cleared 510(K)
- K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)2Cleared 510(K)
- K223853Medartis APTUS® Ulna Plates2Cleared 510(K)
- K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System2Cleared 510(K)
- K230527WishBone Medical Plate and Screw System2Cleared 510(K)
- K222397KLS Martin Level One Rib Fixation System2Cleared 510(K)
- K221938KLS Martin Pure Pectus System2Cleared 510(K)
- K230141LOQTEQ® VA Elbow Plates 2.7/3.5 System2Cleared 510(K)
- K222465Tyber Medical Anatomical Plating System2Cleared 510(K)
- K213059Tibia and Fibula System2Cleared 510(K)
- K222665Medline UNITE® Ankle Fusion Plating System2Cleared 510(K)
- K221150Advanced Bone Plate2Cleared 510(K)
- K223118OIC Variable Angle Small Fragment Locking Plate System2Cleared 510(K)
- K221088Anatomic Bone Plate2Cleared 510(K)
- K221181Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K222637TriMed Wrist Fixation System 32Cleared 510(K)
- K221412ARIX Rib System2Cleared 510(K)
- K221558ALPHALOK Plating System2Cleared 510(K)
- K213108Humerus & Ulna System2Cleared 510(K)
- K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System2Cleared 510(K)
- K213123EVOS Wrist Spanning Plate2Cleared 510(K)
- K222267Arthrex 2.4 mm Volar Distal Radius Plate System2Cleared 510(K)
- K213014Varixis Elbow System2Cleared 510(K)
- K222244Arthrex 3.5 mm Locking Compression Plates2Cleared 510(K)
- K221360Medline UNITE® Medial Malleolus Peg Plate System2Cleared 510(K)
- K221809DePuy Synthes 3.5mm Intrapelvic Acetabular System2Cleared 510(K)
- K213864Bonebridge Osteosynthesis Plating System2Cleared 510(K)
- K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)2Cleared 510(K)
- K221920ARIX Small Fragment System2Cleared 510(K)
- K222194Baby Gorilla®/Gorilla® Plating System2Cleared 510(K)
- K221346Stryker VariAx 2 MIS Calcaneus2Cleared 510(K)
- K221395Footmotion Plating System2Cleared 510(K)
- K220937Arthrex Mini Fragment System2Cleared 510(K)
- K221465Baby Gorilla/Gorilla Plating System2Cleared 510(K)
- K221362Omni Foot and Ankle Plating System2Cleared 510(K)
- K213698CoLink PCR Plating System2Cleared 510(K)
- K212979CalcShift™ Displacement Calcaneal Osteotomy System2Cleared 510(K)
- K220463Osteotomy Truss System (OTS)2Cleared 510(K)
- K212782SternaLock Sternal Closure System2Cleared 510(K)
- K213837Arthrx Fracture Plates2Cleared 510(K)
- K212348ALPHALOK™ Plating System2Cleared 510(K)
- K220244DVR® Crosslock Wrist Spanning Plate (131849181)2Cleared 510(K)
- K212608RibFix Blu Thoracic Fixation System2Cleared 510(K)
- K212601DRPx Locking Distal Radius Plate System2Cleared 510(K)
- K220199AFFINITY Proximal Tibia System2Cleared 510(K)
- K2113242.4mm Distal Radius System2Cleared 510(K)
- K213712Pectus Support Bar System2Cleared 510(K)
- K213005Apollo Ankle Fracture Plating System2Cleared 510(K)
- K201229Intai Anatomic Locking Plate and Screw System2Cleared 510(K)
- K211843PolyLock Plating System2Cleared 510(K)
- K213567Medline UNITE Calcaneal Fracture Plating System2Cleared 510(K)
- K212378Arsenal Ankle Plating System2Cleared 510(K)
- K201510Traufix osteosynthesis, osteotomy, and arthrodesis devices2Cleared 510(K)
- K220136Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K212545FlexitSystem Knee osteotomy system2Cleared 510(K)
- K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate2Cleared 510(K)
- K213591ANTHEM® Fracture System2Cleared 510(K)
- K202914SternaFuse Fixation System2Cleared 510(K)
- K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System2Cleared 510(K)
- K213895Distal Humerus Plating System2Cleared 510(K)
- K212841Pectus Blu Support Bar System2Cleared 510(K)
- K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive2Cleared 510(K)
- K202803Activmotion S DTO2Cleared 510(K)
- K213069CoLink NeoFuse Plating System2Cleared 510(K)
- K213214Xpert Wrist2Cleared 510(K)
- K211650The Radian MIS Bunion System2Cleared 510(K)
- K212640Stratum® Ankle Fusion Plating System2Cleared 510(K)
- K212487CoLink Vallux Plating System2Cleared 510(K)
- K211582LOQTEQ Proximal Humerus Plate 3.5 System2Cleared 510(K)
- K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System2Cleared 510(K)
- K212433Anthem Fracture System2Cleared 510(K)
- K212334GEO Extremity and Ankle Plating System2Cleared 510(K)
- K212297Omni Foot and Ankle Plating System2Cleared 510(K)
- K203817Tyber Medical Anatomical Plating System2Cleared 510(K)
- K203408Summit Patella Plating System2Cleared 510(K)
- K211646FINE Osteotomy2Cleared 510(K)
- K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System2Cleared 510(K)
- K211592Avanti Orthopaedics Ulnar Shortening System2Cleared 510(K)
- K210750Acumed Clavicle Hook Plating System2Cleared 510(K)
- K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM2Cleared 510(K)
- K210837Smith & Nephew Plates and Screws2Cleared 510(K)
- K211695Valkyrie Thoracic Fixation System2Cleared 510(K)
- K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)2Cleared 510(K)
- K202971DRPx Locking Distal Radius Plate System2Cleared 510(K)
- K210290JACE Medical Thoracic Plating System2Cleared 510(K)
- K210157SOLE Medial Column Fusion Plate2Cleared 510(K)
- K210658Volition Plating System2Cleared 510(K)
- K210408DePuy Synthes Variable Angle Locking Patella Plating System2Cleared 510(K)
- K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System2Cleared 510(K)
- K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System2Cleared 510(K)
- K203834Arthrex Patella SuturePlates2Cleared 510(K)
- K210060CoLink Mfx Implant System2Cleared 510(K)
- K201728Versalock Periprosthetic Femur Plates System-GMReis2Cleared 510(K)
- K210043LOQTEQ Distal Lateral Femur Plate 4.5 System2Cleared 510(K)
- K202889Able Medical Devices Valkyrie Thoracic Fixation System2Cleared 510(K)
- K203479ExtremiLOCK Lateral Ankle Fusion Plates2Cleared 510(K)
- K200062Foot and Ankle System2Cleared 510(K)
- K210192A.L.P.S. Clavicle Plating System2Cleared 510(K)
- K203294Arthrex Pilon Fusion System2Cleared 510(K)
- K203474Biomet Microfixation RibFix Advantage System2Cleared 510(K)
- K203405EVOS Large Fragment Plating System2Cleared 510(K)
- K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2Cleared 510(K)
- K203511Baby Gorilla/Gorilla Plating System2Cleared 510(K)
- K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System2Cleared 510(K)
- K202657Javelin Tailor's Bunion Fixation System2Cleared 510(K)
- K202959PolyLock Plating System2Cleared 510(K)
- K202764Ortho Solutions Plating System2Cleared 510(K)
- K202307Activ Fuse2Cleared 510(K)
- K201918EVOS Large Fragment Plating System2Cleared 510(K)
- K202912ARIX Ankle Distal Tibia System2Cleared 510(K)
- K202496ANTHEM Fracture System2Cleared 510(K)
- K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System2Cleared 510(K)
- K201962Skeletal Dynamics Ulnar Shortening Plating System2Cleared 510(K)
- K201917Piccolo Composite Proximal Tibia Plate System2Cleared 510(K)
- K201656ARIX Elbow System2Cleared 510(K)
- K201959DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System2Cleared 510(K)
- K201578DePuy Synthes Variable Angle Locking Patella Plating System2Cleared 510(K)
- K201677Arthrex Mesh Plates2Cleared 510(K)
- K201132Arthrex Compression Screws2Cleared 510(K)
- K200785Stratum™ Reduced Size Foot Plating System2Cleared 510(K)
- K201321DePuy Synthes 2.7mm VA LCP Clavicle Plate System2Cleared 510(K)
- K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)2Cleared 510(K)
- K200513DAC Dynamic Active Compression Plate2Cleared 510(K)
- K201149CoLink Plating System2Cleared 510(K)
- K193345Arthrex DynaNite Compression Plate2Cleared 510(K)
- K201235Arthrex MaxForce MTP Compression Plates and Screws2Cleared 510(K)
- K200834Lever Action Plate System2Cleared 510(K)
- K200398AxSOS 3 AF System and AxSOS 3 Ti System2Cleared 510(K)
- K200538Skeletal Dynamics Forearm Plating System2Cleared 510(K)
- K200246JPS JuniOrtho Plating System2Cleared 510(K)
- K200701Skeletal Dynamics Midshaft Humerus Plating System2Cleared 510(K)
- K200367Distal Humerus Plating System2Cleared 510(K)
- K200961Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K200762CoLink Cfx Plating System2Cleared 510(K)
- K191867ATLAS Plating System2Cleared 510(K)
- K200108GEO 1st MTP Joint Arthrodesis Plating System2Cleared 510(K)
- K193639APTUS® Foot 2.8-3.5 System2Cleared 510(K)
- K193633APTUS® Ankle Trauma System 2.8/3.52Cleared 510(K)
- K193614FINE Osteotomy around the knee2Cleared 510(K)
- K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range2Cleared 510(K)
- K191057Park's Pectus System2Cleared 510(K)
- K193616ARIX Ankle System2Cleared 510(K)
- K192619Pitkar Locked Plating System2Cleared 510(K)
- K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System2Cleared 510(K)
- K190842Comus Locking Plate systems2Cleared 510(K)
- K192984APTUS Clavicle System2Cleared 510(K)
- K193222Tyber Medical Anatomical Plating System2Cleared 510(K)
- K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System2Cleared 510(K)
- K193452MotoBAND CP Implant System2Cleared 510(K)
- K192696TriMed ASET Foot Plating System2Cleared 510(K)
- K182718Mini and Micro Fragments Reconstruction System – GMReis2Cleared 510(K)
- K192356Airlock Centrolock Osteosynthesis Implant System2Cleared 510(K)
- K191118Avanti Distal Radius and Forearm System2Cleared 510(K)
- K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System2Cleared 510(K)
- K192473Exsomed Wrist Plating System2Cleared 510(K)
- K192675VariAx Foot2Cleared 510(K)
- K192592Axis Plating System2Cleared 510(K)
- K192323PolyLock Small Bone Plating System2Cleared 510(K)
- K190391TDM Plate and Screw Systems2Cleared 510(K)
- K191972ARIX Wrist System2Cleared 510(K)
- K192297APTUS Wrist Arthrodesis Plates2Cleared 510(K)
- K192327DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile2Cleared 510(K)
- K192504Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K190953Arthrex Minimally Invasive Ankle Fusion Plate2Cleared 510(K)
- K191326Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module2Cleared 510(K)
- K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module2Cleared 510(K)
- K191848APTUS Wrist Spanning Plates 2.52Cleared 510(K)
- K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws2Cleared 510(K)
- K192217NCB Plating System Distal Femur and Proximal Tibia2Cleared 510(K)
- K191412VariAx 2 System, VariAx 2 Mini Fragment System2Cleared 510(K)
- K192021NCB Polyaxial Locking Plate System2Cleared 510(K)
- K191009Arsenal Plating System2Cleared 510(K)
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System2Cleared 510(K)
- K190992OrthoPediatrics PediFoot Deformity Corrections System2Cleared 510(K)
- K182818LOQTEQ VA Calcaneus Plate 3.52Cleared 510(K)
- K191535CoLink® Mini Plating System2Cleared 510(K)
- K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional2Cleared 510(K)
- K191711ORTHOLOC™ SPS Shoulder Plating System2Cleared 510(K)
- K190750DePuy Synthes Plates and Screws Portfolio2Cleared 510(K)
- K182785LOQTEQ VA Foot Plates 2.52Cleared 510(K)
- K182650Arzzt Distal Radius and Ulna System2Cleared 510(K)
- K190388RIVAL View Plating Systems and Reduce Fracture Plating Systems2Cleared 510(K)
- K183620PROSTEP TBC Implant System2Cleared 510(K)
- K190670ORTHOLOC™ 2 Lapidus with Rotation System2Cleared 510(K)
- K190409MatrixRIB Fixation System2Cleared 510(K)
- K190415ATLAS Plating System2Cleared 510(K)
- K190658MIS Bunion Plating System2Cleared 510(K)
- K190365Baby Gorilla/Gorilla Plating System2Cleared 510(K)
- K190253EVOS Small Fragment Upper Extremity Plates Line Additions2Cleared 510(K)
- K183172Stryker SternalPlate System2Cleared 510(K)
- K181843MLP Special Locking Bone Plate System2Cleared 510(K)
- K181872MIS Bunion System2Cleared 510(K)
- K183317AdvantageRib System2Cleared 510(K)
- K182991EPIC Extremity Fusion Plate System2Cleared 510(K)
- K183321Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K183011Additive Orthopaedics Patient Specific 3D Locking Lattice Plates2Cleared 510(K)
- K182783DePuy Synthes Trauma Orthopedic Nail Implants2Cleared 510(K)
- K180821TruMatch Graft Cage - Long Bone2Cleared 510(K)
- K182810Distal Radius Plating System2Cleared 510(K)
- K181806ARIX Sternal System2Cleared 510(K)
- K182201Stratum™ Foot Plating System2Cleared 510(K)
- K182179AdvantageRib Anterior System2Cleared 510(K)
- K181820Medline Unite Mini Plates and Screws2Cleared 510(K)
- K180310DePuy Synthes Trauma Orthopedic Plates and Screws2Cleared 510(K)
- K182466AOS Calcaneal Plating System2Cleared 510(K)
- K180554ANTHEM Fracture System2Cleared 510(K)
- K180213Titanium TomoFix Medial High Tibia Plate Anatomical2Cleared 510(K)
- K182015Piccolo Composite® Plate System2Cleared 510(K)
- K181091AxSOS 3 Ti2Cleared 510(K)
- K182492Geminus Volar Distal Radius Plate System2Cleared 510(K)
- K181587ORTHOLOC SPS Shoulder Plating System2Cleared 510(K)
- K180736WishBone Medical Plate and Screw System2Cleared 510(K)
- K180972ARIX Clavicle System2Cleared 510(K)
- K182402CoLink View Plating System2Cleared 510(K)
- K171904Tandry Locking Plate System2Cleared 510(K)
- K181035AOS Small Fragment Plating System Lite2Cleared 510(K)
- K181009APTUS CMC-I Fusion Plate System2Cleared 510(K)
- K181533EVOS Wrist Fracture Plating System2Cleared 510(K)
- K181425APTUS® Proximal Humerus System2Cleared 510(K)
- K180150PL8 Wrist Reconstruction Plate2Cleared 510(K)
- K181113CoLink™ Afx Plating System2Cleared 510(K)
- K181067AlignX Ankle Fusion System2Cleared 510(K)
- K180808Omni Foot Plating System2Cleared 510(K)
- K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments2Cleared 510(K)
- K171690Trident Extremity Fixation System2Cleared 510(K)
- K173767A. L. P. S. Clavicle Plating System2Cleared 510(K)
- K171624IXOS Radius Plate System2Cleared 510(K)
- K173930PYTHON Plate Trial Instruments2Cleared 510(K)
- K172148Anchorage Bone Plating System2Cleared 510(K)
- K171808TDM Plate and Screw System2Cleared 510(K)
- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws2Cleared 510(K)
- K173746Activmotion Range2Cleared 510(K)
- K172294Osteotomy Truss System (OTS)2Cleared 510(K)
- K173641Activ Ankle2Cleared 510(K)
- K173293EVOS Small Fragment Upper Extremity Plates2Cleared 510(K)
- K171372Alians Elbow Locking Plating System2Cleared 510(K)
- K172973Life Spine Foot and Ankle Plating System2Cleared 510(K)
- K172886Breakaway Screw System2Cleared 510(K)
- K172350AxSOS 3 Ti2Cleared 510(K)
- K172786MDS Plating System2Cleared 510(K)
- K172425OrthoPediatrics Wrist Fusion Plate2Cleared 510(K)
- K172008ARIX Humerus System2Cleared 510(K)
- K173121Ankle Fusion Plating System2Cleared 510(K)
- K172300CoLink View Plating System2Cleared 510(K)
- K172178Minimally Invasive Bunion Plating System2Cleared 510(K)
- K173166ANTHEM Fracture System2Cleared 510(K)
- K172441EPIC Extremity Fracture Plate System2Cleared 510(K)
- K172260Omni Foot Plating System2Cleared 510(K)
- K171293G3™ Active Plate® Miniature System2Cleared 510(K)
- K171852DARCO Locking Bone Plate System2Cleared 510(K)
- K170705ARIX Wrist System2Cleared 510(K)
- K172170APTUS(R) Wrist 2.5 System2Cleared 510(K)
- K171510Footmotion Plating System2Cleared 510(K)
- K170547Arthrex Mesh Plate System2Cleared 510(K)
- K171173OrthoPediatrics Titanium PediPlates® System2Cleared 510(K)
- K172262EVOS Small Fragment Plating System2Cleared 510(K)
- K170979ARIX Ankle Fibula Hook Plate System2Cleared 510(K)
- K170780ARIX Foot System (2.3/2.8)2Cleared 510(K)
- K162507Arzzt 3.5 / 4.5 Small & Large Fragments System2Cleared 510(K)
- K170313ARIX Ankle Distal Tibia System2Cleared 510(K)
- K171285ARIX Diaphysis System2Cleared 510(K)
- K170518In2Bones Fracture and Correction System2Cleared 510(K)
- K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S2Cleared 510(K)
- K171590Distal Elbow Plating System2Cleared 510(K)
- K170727VariAx 2 Compression Plating System2Cleared 510(K)
- K163593Additive Orthopaedics Bunion System2Cleared 510(K)
- K170843Alians Fragment Specific2Cleared 510(K)
- K162674BioPro Foot Plating Systems2Cleared 510(K)
- K170457EVOS Small Fragment Lower Extremity Plates2Cleared 510(K)
- K170401Piccolo Composite® Plate System2Cleared 510(K)
- K170771VariAx 2 Foot System2Cleared 510(K)
- K163293Colink™ Plating System2Cleared 510(K)
- K162380Locking Plate System2Cleared 510(K)
- K170887EVOS Small Fragment Plating System2Cleared 510(K)
- K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension2Cleared 510(K)
- K162154Pantheon Medical Balanced Plating System2Cleared 510(K)
- K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System2Cleared 510(K)
- K170214Additive Orthopaedics Locking Lattice Plate2Cleared 510(K)
- K163361ANTHEM™ Fracture System2Cleared 510(K)
- K170310Alians Clavicle range2Cleared 510(K)
- K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System2Cleared 510(K)
- K162898Olecranon Plating System2Cleared 510(K)
- K163003Y3 Proximal Femoral Plate System2Cleared 510(K)
- K163039ORTHOLOC® 3Di Small Bones Plating2Cleared 510(K)
- K170124Level One Hand Plating System2Cleared 510(K)
- K162841VariAx Distal Radius Plating System, VariAx 2 System2Cleared 510(K)
- K162391AlignMATE™ Lapidus Arthrodesis System2Cleared 510(K)
- K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long2Cleared 510(K)
- K161861APTUS® Coronoid 2.02Cleared 510(K)
- K162439AxSOS 3 Ti; Stryker Plating System2Cleared 510(K)
- K163044ORTHOLOC® 3Di Ankle Fracture Plating System2Cleared 510(K)
- K161303dynaMX™ Compression Plate2Cleared 510(K)
- K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate System2Cleared 510(K)
- K163086VLP MINI-MOD 2.0mm Column Plates2Cleared 510(K)
- K162974Biomet Microfixation RibFix Blu Thoracic Fixation System2Cleared 510(K)
- K162829Medline UNITE® Ankle Fracture Plating System2Cleared 510(K)
- K163007Biomet Microfixation SternaLock 360 Sternal Closure System2Cleared 510(K)
- K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.52Cleared 510(K)
- K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.52Cleared 510(K)
- K162078EVOS Small Fragment Plating System2Cleared 510(K)
- K161665VLP Wrist Fracture System2Cleared 510(K)
- K161913AOS Small Fragment Plating System2Cleared 510(K)
- K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer2Cleared 510(K)
- K161590MatrixRIB Fixation System2Cleared 510(K)
- K161448Footmotion Plating System2Cleared 510(K)
- K162635Distal Radius Plating System2Cleared 510(K)
- K162424Ulna Plating System2Cleared 510(K)
- K162307OrthoPediatrics Locking Proximal Femur System Cortical Screws2Cleared 510(K)
- K161746ARIX Hand System2Cleared 510(K)
- K153207Additive Orthopaedics Bone Wedge System2Cleared 510(K)
- K152289Alians Elbow Locking Plating System2Cleared 510(K)
- K161292Distal Radius Plating System2Cleared 510(K)
- K161037Tarsa-Link Stand-Alone Wedge Fixation System2Cleared 510(K)
- K153573Converge2Cleared 510(K)
- K161896Biomet Microfixation Sternal Closure System2Cleared 510(K)
- K161864ARIX Foot System2Cleared 510(K)
- K161048Conventus Orthopaedics Ulna Fixation System2Cleared 510(K)
- K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System2Cleared 510(K)
- K160995NEOVIEW Plating System2Cleared 510(K)
- K153379AxSOS 3Ti2Cleared 510(K)
- K161041OsteoMed ExtremiLOCK Wrist Plating System2Cleared 510(K)
- K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.2Cleared 510(K)
- K152062BIOFOAM Bone Wedge2Cleared 510(K)
- K160633G3(TM) Active Plate(R) Small Fragment System2Cleared 510(K)
- K160300MotoBand(TM) CP Implant System2Cleared 510(K)
- K160177Gridlock Ankle Plating System2Cleared 510(K)
- K153482KLS Martin Thoracic Plating System2Cleared 510(K)
- K160191Align Anterior Ankle Fusion Plate2Cleared 510(K)
- K152253Biomet Microfixation RibFix Blu Thoracic Fixation System2Cleared 510(K)
- K160002Piccolo Composite(R) Distal Volar Radius Plate System2Cleared 510(K)
- K151508IRENE Locking Compression Plate System2Cleared 510(K)
- K153340Epic Extremity Plate System2Cleared 510(K)
- K151735TriMed Humeral Supracondylar Fixation System2Cleared 510(K)
- K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System2Cleared 510(K)
- K153034aap LOQTEQ VA Radius Set 2.52Cleared 510(K)
- K151468ARIX Wrist System2Cleared 510(K)
- K153531Treace Medical Concepts (TMC) Plating System2Cleared 510(K)
- K152548AXI+LINE Proximal Bunion Correction System2Cleared 510(K)
- K152145OsteoMed ExtremiLOCK Wrist Plating System2Cleared 510(K)
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction System2Cleared 510(K)
- K152306MotoBand¿ CP Implant System2Cleared 510(K)
- K152732AOS Small Fragment Plating System2Cleared 510(K)
- K152000SMV Scientific Bone Plate and Screw System2Cleared 510(K)
- K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System2Cleared 510(K)
- K152242G3¿ Active Plate® Large Fragment System2Cleared 510(K)
- K152976VLP Mini-Mod Talus Plates2Cleared 510(K)
- K152256RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws2Cleared 510(K)
- K151019SternaLock® 360 Sternal Closure System2Cleared 510(K)
- K152312RECON system-V-TEK-IVP Plates and Screws2Cleared 510(K)
- K151886Acumed Ankle and Small Fragment Base Set Update2Cleared 510(K)
- K151769Anchorage 2 CP System2Cleared 510(K)
- K152142RECON system - MPJ-Plates2Cleared 510(K)
- K151442TOTAL COMPRESSION PLATING (TCP) SYSTEM2Cleared 510(K)
- K151732Arthrex Fracture Plates2Cleared 510(K)
- K143721PRCT22Cleared 510(K)
- K151379Conventus PRS System2Cleared 510(K)
- K151277Airlock® osteosynthesis plate system2Cleared 510(K)
- K151407RECON system2Cleared 510(K)
- K151057WASTON Metallic Bone Plate and Screw Systems2Cleared 510(K)
- K151879VariAx 2 One-Third Tubular Plating System2Cleared 510(K)
- K151235Medline Foot Plates and Screws2Cleared 510(K)
- K142943Metallic Locking Bone Plate and Screw2Cleared 510(K)
- K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws2Cleared 510(K)
- K151178VariAx 2 Wrist Fusion System2Cleared 510(K)
- K142906APTUS Wrist 2.5 System2Cleared 510(K)
- K143002Metallic Locking Bone Plate and Screw System2Cleared 510(K)
- K143496Piccolo Composite Plate System2Cleared 510(K)
- K142724BIOFOAM Bone Wedge2Cleared 510(K)
- K150675Dorsal Spanning Plate2Cleared 510(K)
- K150649G3 Active Plate Large Fragment System2Cleared 510(K)
- K150520DARCO Locking Bone Plate System2Cleared 510(K)
- K150456Arthrex Plates, Screws, and Staples2Cleared 510(K)
- K142581APTUS Foot System2Cleared 510(K)
- K143523Airlock osteosynthesis plate system2Cleared 510(K)
- K143385Acumed Ankle Plating System2Cleared 510(K)
- K143749Arthrex Distal Radius System2Cleared 510(K)
- K143697Biomet Proximal Humerus Plating System2Cleared 510(K)
- K143365Eminent Foot Plate System2Cleared 510(K)
- K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM2Cleared 510(K)
- K150368Tarsa-Link Wedge Fixation System2Cleared 510(K)
- K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)2Cleared 510(K)
- K141493PROXIMAL HUMERUS PLATING SYSTEM2Cleared 510(K)
- K143717Treace Medical Concepts(TMC) Plating System2Cleared 510(K)
- K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS2Cleared 510(K)
- K141825IDEAL Locking Plate System2Cleared 510(K)
- K150009Baide2Cleared 510(K)
- K142823Biomet Microfixation Thoracic Fixation System2Cleared 510(K)
- K150121Zimmer Periarticular Plating System2Cleared 510(K)
- K141548HIGH TIBIAL OSTEOTOMY SYSTEM2Cleared 510(K)
- K143061Activ Ankle Locking Plating System2Cleared 510(K)
- K143394Acumed Small Fragment Base Set2Cleared 510(K)
- K143139Arthrex Fracture System2Cleared 510(K)
- K143023Nitinol Compression Plating System2Cleared 510(K)
- K142502ALIANS ULNA LOCKING PLATING SYSTEM2Cleared 510(K)
- K143138AxSOS 3 Ti Locking Plate System2Cleared 510(K)
- K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws2Cleared 510(K)
- K142419Mini and Micro Fragments Reconstruction System-NEOFIX2Cleared 510(K)
- K143025TOTAL COMPRESSION PLATING SYSTEM2Cleared 510(K)
- K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers2Cleared 510(K)
- K142938G3 Active Plate Large Fragment System2Cleared 510(K)
- K142836Zimmer Plates and Screws (ZPS), Forte Screws2Cleared 510(K)
- K142484Sternal Closure System2Cleared 510(K)
- K142579Zimmer Periarticular Plating System2Cleared 510(K)
- K142418I.T.S. Hand Locking Plates System - HLS2Cleared 510(K)
- K141905PRO-LINK WEDGE SYSTEM2Cleared 510(K)
- K142306Flower Upper Extremity Plating Set2Cleared 510(K)
- K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM2Cleared 510(K)
- K142135REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION2Cleared 510(K)
- K140892DISTAL ELBOW PLATING SYSTEM2Cleared 510(K)
- K142121VALOR HINDFOOT FUSION NAIL SYSTEM2Cleared 510(K)
- K141735ARTHREX ANKLE FUSION PLATING SYSTEM2Cleared 510(K)
- K140508ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS2Cleared 510(K)
- K141734ZIMMER PERIARTICULAR LOCKING SYSTEM2Cleared 510(K)
- K141517ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES2Cleared 510(K)
- K141992VARIAX 2 SYSTEM2Cleared 510(K)
- K141823AAP LOQTEC CLAVICLE PLATES 2.7/3.52Cleared 510(K)
- K141241MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM2Cleared 510(K)
- K140431PEDILOC FRAGMENT SYSTEM2Cleared 510(K)
- K133840Kangli Locking Plate System2Cleared 510(K)
- K141489LINOS MOH HAND PLATING SYSTEM2Cleared 510(K)
- K141784ORTHO SOLUTIONS ULTOS PLATING SYSTEM2Cleared 510(K)
- K141677VARIAX ELBOW PLATING SYSTEM2Cleared 510(K)
- K140876VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW2Cleared 510(K)
- K141430VARIAX DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEM2Cleared 510(K)
- K141417CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW2Cleared 510(K)
- K140531BIOFOAM BONE WEDGE2Cleared 510(K)
- K141478ARTHREX FRACTURE PLATES AND SCREWS2Cleared 510(K)
- K141045MBD PLATE SYSTEM2Cleared 510(K)
- K141232APTUS ULNA SHORTENING 2.52Cleared 510(K)
- K141204VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM2Cleared 510(K)
- K141121AXSOS 3 TI LOCKING PLATE SYSTEM2Cleared 510(K)
- K141383ACUMED HAND FRACTURE SYSTEM2Cleared 510(K)
- K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM2Cleared 510(K)
- K140226OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.52Cleared 510(K)
- K140565VARIAX 2 COMPRESSION PLATING SYSTEM2Cleared 510(K)
- K140792SALVATION 3DI PLATING SYSTEM2Cleared 510(K)
- K140724MSP METATARSAL SHORTENING SYSTEM2Cleared 510(K)
- K140622DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE2Cleared 510(K)
- K140607AAP LOQTEC(R) OLECRANON PLATE2Cleared 510(K)
- K140814EVOS MINI-FRAGMENT PLATING SYSTEM2Cleared 510(K)
- K133616MATRIXRIB FIXATION SYSTEM2Cleared 510(K)
- K140216ORTHOPEDIC FIXATION SYSTEMS2Cleared 510(K)
- K140617PINIT SMALL BONE FUSION SYSTEM2Cleared 510(K)
- K140769VARIAX 2 SYSTEM2Cleared 510(K)
- K140397PARALOCK PLATING SYSTEM / TUFFNEK SCREW2Cleared 510(K)
- K140372FRAGMENT PLATE SYSTEM2Cleared 510(K)
- K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.02Cleared 510(K)
- K140376VARIAX 2 SYSTEM2Cleared 510(K)
- K140259VARIAX CLAVICLE HOOK PLATE2Cleared 510(K)
- K133939MODIFIED DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K133930FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET2Cleared 510(K)
- K133974VARIAX DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K140107EMERGE MEDICAL DISTAL RADIUS SET2Cleared 510(K)
- K140119EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM2Cleared 510(K)
- K140098EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM2Cleared 510(K)
- K133525LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM2Cleared 510(K)
- K133668AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL2Cleared 510(K)
- K133715CHARLOTTE CLAW PLATE SYSTEM2Cleared 510(K)
- K133536EMERGE MEDICAL BONE PLATE SYSTEM2Cleared 510(K)
- K133691EXTRIMILOCK ANKLE PLATING SYSTEM2Cleared 510(K)
- K131552CONVENTUS DRS2Cleared 510(K)
- K132886SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM2Cleared 510(K)
- K133541EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM2Cleared 510(K)
- K133675AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.52Cleared 510(K)
- K130614BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS2Cleared 510(K)
- K133452EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM2Cleared 510(K)
- K132296D-RAD SMART PACK2Cleared 510(K)
- K132769ACUMED HAND PLATING SYSTEM2Cleared 510(K)
- K132787LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE2Cleared 510(K)
- K132876ARIX HAND LOCKING SYSTEM2Cleared 510(K)
- K133246ZIMMER DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K132594CROSSCHECK PLATING SYSTEM2Cleared 510(K)
- K1334371ST MTP PLATE2Cleared 510(K)
- K132898A.L.P.S. CALCANEAL PLATING SYSTEM2Cleared 510(K)
- K133102FLOWER ANKLE PLATING SET2Cleared 510(K)
- K131782LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.52Cleared 510(K)
- K131834WOLF LONG BONE PLATE SYSTEM2Cleared 510(K)
- K131566ARIX HAND SYSTEM2Cleared 510(K)
- K1318672.5MM INLINE FUSION PLATE2Cleared 510(K)
- K132502VARIAX 2 SYSTEM2Cleared 510(K)
- K131186SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM2Cleared 510(K)
- K132642LOCKING PLATE SYSTEM2Cleared 510(K)
- K132554AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.52Cleared 510(K)
- K130510ARTHREX COMPRESSION PLATES2Cleared 510(K)
- K132591MAXLOCK EXTREME SYSTEM2Cleared 510(K)
- K131764ACUMED WRIST SPANNING PLATE2Cleared 510(K)
- K131311ARIX FOOT SYSTEM2Cleared 510(K)
- K131657FLOWER SMALL AND MEDIUM IMPLANT SET2Cleared 510(K)
- K132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT2Cleared 510(K)
- K131759METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM2Cleared 510(K)
- K131722I.T.S. EXTREMITY FIXATION SYSTEMS2Cleared 510(K)
- K131360INTEGRA TITANIUM BONE WEDGE2Cleared 510(K)
- K123347NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.02Cleared 510(K)
- K130731STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW2Cleared 510(K)
- K131670LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)2Cleared 510(K)
- K131480EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM2Cleared 510(K)
- K131474ARTHREX DISTAL RADIUS PLATE SYSTEM2Cleared 510(K)
- K130008DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING2Cleared 510(K)
- K130774UNIVERSAL DISTAL RADIUS SYSTEM2Cleared 510(K)
- K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM2Cleared 510(K)
- K131380ACUMED TOTALW RIST FUSION PLATING SYSTEM2Cleared 510(K)
- K1301854WEB OSTEOTOMY BONE WEDGE2Cleared 510(K)
- K131132PELVIS II IMPLANT SYSTEM2Cleared 510(K)
- K131093ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM2Cleared 510(K)
- K130964GRIDLOCK PLATING SYSTEM2Cleared 510(K)
- K130108DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS2Cleared 510(K)
- K130340LOCKING BONE PLATES AND SCREWS2Cleared 510(K)
- K123241ARTHREX FRACTURE PLATES2Cleared 510(K)
- K123562FLOWER SMALL AND MEDIUM BONE IMPLANTS2Cleared 510(K)
- K123964AXSOS 3 TI LOCKING PLATE SYSTEM2Cleared 510(K)
- K122770BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-8312Cleared 510(K)
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- K113652LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T2Cleared 510(K)
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- K111620SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS2Cleared 510(K)
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- K092812SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES2Cleared 510(K)
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- K093900EDGELOCK2Cleared 510(K)
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- K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATE2Cleared 510(K)
- K091609NEWDEAL COMPRESSION PLATE2Cleared 510(K)
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- K090440HINGE PEDIATRIC PLATING SYSTEM2Cleared 510(K)
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- K090047SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM2Cleared 510(K)
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- K083213SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES2Cleared 510(K)
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- K0833642.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-1312204242Cleared 510(K)
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- K082807SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS2Cleared 510(K)
- K082624SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES2Cleared 510(K)
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- K081623SYNTHES RIB FIXATION SYSTEM2Cleared 510(K)
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- K073432TRAUSON BONE PLATE2Cleared 510(K)
- K081353SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES2Cleared 510(K)
- K081407ORTHOPEDIATRICS PEDIPLATES SYSTEM2Cleared 510(K)
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- K081373EVOLVE EPS SYSTEM2Cleared 510(K)
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- K073460SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES2Cleared 510(K)
- K073375NEWDEAL TIBIAXYS SYSTEM2Cleared 510(K)
- K071809ENSPLINTRX BONE FIXATION SYSTEM2Cleared 510(K)
- K073344ORTHOPEDIATRICS PLATING SYSTEM2Cleared 510(K)
- K073535BIOFOAM BONE WEDGE2Cleared 510(K)
- K073186SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM2Cleared 510(K)
- K072832ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM2Cleared 510(K)
- K072818PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS2Cleared 510(K)
- K072740MONDEAL EXTREMITY BONE FIXATION SYSTEM2Cleared 510(K)
- K0724234.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.2Cleared 510(K)
- K072083SMALL FRAGMENT LOCKING PLATING SYSTEM2Cleared 510(K)
- K070592SMALL BONE WEDGE2Cleared 510(K)
- K071797MONDEAL HAND CONTOUR SYSTEM2Cleared 510(K)
- K071798MONDEAL DISTAL RADIUS SYSTEM2Cleared 510(K)
- K071577BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER2Cleared 510(K)
- K072175TITANIUM HIP TOOL LOCKING PLATE2Cleared 510(K)
- K071563PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM2Cleared 510(K)
- K071549SBI RHEAD PLATING SYSTEM2Cleared 510(K)
- K071105OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM2Cleared 510(K)
- K063275DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)2Cleared 510(K)
- K071325BIOMET VARIABLE LOCKING PLATE SYSTEM2Cleared 510(K)
- K071715ACUMED CONGRUENT BONE PLATE SYSTEM2Cleared 510(K)
- K071264SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE2Cleared 510(K)
- K071184SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM2Cleared 510(K)
- K070946SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES2Cleared 510(K)
- K070793SBI DISTAL RADIUS VOLAR PLATING SYSTEM2Cleared 510(K)
- K070823GROWTH CONTROL PLATING SYSTEM2Cleared 510(K)
- K070447NEWDEAL COMPRESSION PLATE2Cleared 510(K)
- K070208SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES2Cleared 510(K)
- K070169KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE2Cleared 510(K)
- K063875STRYKER FOOT PLATING SYSTEM2Cleared 510(K)
- K063726PLC SUTURE ANCHOR2Cleared 510(K)
- K070170DALL-MILES SYSTEM2Cleared 510(K)
- K070241MODIFICATION TO LAPIDUS PLATE2Cleared 510(K)
- K070160MODIFICATION TO TTC PLATES2Cleared 510(K)
- K063820LISFRANC PLATE2Cleared 510(K)
- K063831BASAL DORSAL PLATES2Cleared 510(K)
- K063672FIBULA PLATE PROLOCK WITH ANGULAR STABILITY2Cleared 510(K)
- K063410INION CPS/OTPS FREEDOMPLATE2Cleared 510(K)
- K063709TS-BONE HIP TOOL2Cleared 510(K)
- K063009FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)2Cleared 510(K)
- K063166I.T.S. PELVIC RECONSTRUCTION SYSTEM2Cleared 510(K)
- K063095HUMERUS LOCKING PLATING SYSTEM2Cleared 510(K)
- K063506LORENZ STERNAL CLOSURE SYSTEM2Cleared 510(K)
- K063049SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM2Cleared 510(K)
- K063020INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM2Cleared 510(K)
- K063460ACUMED CONGRUENT BONE PLATE SYSTEM2Cleared 510(K)
- K063303UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS2Cleared 510(K)
- K063033MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT2Cleared 510(K)
- K062498PROFYLE SYSTEM2Cleared 510(K)
- K062903SBI CARPAL FUSION PLATE2Cleared 510(K)
- K062564SYNTHES LCP DISTAL FEMUR PLATES2Cleared 510(K)
- K062494EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM2Cleared 510(K)
- K062747ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM2Cleared 510(K)
- K062216PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM2Cleared 510(K)
- K061973SYNTHES 3.5MM SPRING PLATE2Cleared 510(K)
- K061940SYNTHES LCP ANKLE ARTHRODESIS PLATES2Cleared 510(K)
- K051165KLS MARTIN STERNAL TALON2Cleared 510(K)
- K061917DISTAL RADIUS LOCKING PLATING SYSTEM2Cleared 510(K)
- K061808DARCO LOCKING BONE PLATE SYSTEM2Cleared 510(K)
- K061955RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS2Cleared 510(K)
- K061753SYNTHES (USA) CLAVICLE HOOK PLATES2Cleared 510(K)
- K060474LISFRANC PLATE2Cleared 510(K)
- K053624MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM2Cleared 510(K)
- K061400CALCANEAL TRAUMA SYSTEM2Cleared 510(K)
- K061211NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES2Cleared 510(K)
- K061352PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY2Cleared 510(K)
- K061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM2Cleared 510(K)
- K061098EBI OPTILOCK PERIARTICULAR PLATING SYSTEM2Cleared 510(K)
- K061012AXSOS PLUS LOCKING PLATE SYSTEM2Cleared 510(K)
- K060476LAPIDUS PLATE2Cleared 510(K)
- K060473TTC PLATE2Cleared 510(K)
- K060969POLYAX LOCKED PLATING SYSTEM2Cleared 510(K)
- K060798STRYKER PLATING SYSTEM2Cleared 510(K)
- K060294DIAPHYSEAL PLATE2Cleared 510(K)
- K060156STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM2Cleared 510(K)
- K060514STRYKER PLATING SYSTEM2Cleared 510(K)
- K053182DRLOCK DISTAL RADIUS VOLAR SYSTEM2Cleared 510(K)
- K060041TRIMED BONE PLATES2Cleared 510(K)
- K053408NEXA BONE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K052901ARTHREX TENSIONLOK2Cleared 510(K)
- K052683SYNTHES (USA) STERNAL FIXATION SYSTEM2Cleared 510(K)
- K052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE2Cleared 510(K)
- K052041COLLAGEN BONE HEALING PROTECTIVE SHEET2Cleared 510(K)
- K052294SHOULDER NAIL PLATE2Cleared 510(K)
- K052368OLECRANONPLATE WITH ANGULAR STABILITY2Cleared 510(K)
- K052677SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)2Cleared 510(K)
- K052538S-BONE HIP TOOL2Cleared 510(K)
- K052390SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION2Cleared 510(K)
- K052614LOW PROFILE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K052248DORSAL NAIL PLATE, ANATOMICAL2Cleared 510(K)
- K052152B-BOP PLATE2Cleared 510(K)
- K052150VOLAR PLATE SYSTEM2Cleared 510(K)
- K051986SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES2Cleared 510(K)
- K051945MIOT PLATING SYSTEM2Cleared 510(K)
- K051747SBI WRISTFIT2Cleared 510(K)
- K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K052011PILONPLATE WITH ANGULAR STABILITY2Cleared 510(K)
- K051908CHARLOTTE COMPRESSION PLATE2Cleared 510(K)
- K050657MONDEAL CONTOUR HO SYSTEM2Cleared 510(K)
- K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-20052Cleared 510(K)
- K051884CHARLOTTE SMALL MTP FUSION PLATE2Cleared 510(K)
- K050681OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES2Cleared 510(K)
- K051410ACUMED RIB CONGRIENT BONE PLATE SYSTEM2Cleared 510(K)
- K051735PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY2Cleared 510(K)
- K051412HUMERAL HEAD PLATE WITH ANGULAR STABILITY2Cleared 510(K)
- K051155SOLCO 4CIS GENERAL PLATE SYSTEM2Cleared 510(K)
- K050852CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM2Cleared 510(K)
- K050868MAXLOCK2Cleared 510(K)
- K051181CUSTOM-HIP TOOL2Cleared 510(K)
- K051032TITANIUM-HIP TOOL2Cleared 510(K)
- K051083ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM2Cleared 510(K)
- K050646SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES2Cleared 510(K)
- K050462SBI HAND FIXATION SYSTEM (TM)2Cleared 510(K)
- K050101THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-102Cleared 510(K)
- K050607SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)2Cleared 510(K)
- K050512STRYKER LOCKED PLATING SYSTEM2Cleared 510(K)
- K050492INTEGRA BONE FIXATION SYSTEM2Cleared 510(K)
- K050110SYNTHES (USA) LCP MODULAR FOOT PLATES2Cleared 510(K)
- K050121ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 23592Cleared 510(K)
- K043560PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 23592Cleared 510(K)
- K043263TRIMED OSTEOTOMY PLATE2Cleared 510(K)
- K043227PERIARTICULAR LOCKING PLATES, 2358 SERIES2Cleared 510(K)
- K042766ORTHOFIX VOLAR DISTAL RADIAL PLATE2Cleared 510(K)
- K042695NCB PLATING SYSTEM2Cleared 510(K)
- K042598PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES2Cleared 510(K)
- K042355SYNTHES (USA) LCP WRIST FUSION PLATES2Cleared 510(K)
- K042437DORSAL INTRAMEDULLARY PLATE2Cleared 510(K)
- K042377SYNTHES LOW PROFILE RECONSTRUCTION PLATES2Cleared 510(K)
- K042205BONE FUSION PLATE SYSTEM2Cleared 510(K)
- K042237EBI PERIARTICULAR PLATING SYSTEM2Cleared 510(K)
- K041965ARTHREX HUMERAL FRACTURE PLATES AND SCREWS2Cleared 510(K)
- K041860SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG2Cleared 510(K)
- K041786CALCAMEA PLATE2Cleared 510(K)
- K041601SURFIX KNEE OSTEOTOMY SYSTEM2Cleared 510(K)
- K041461KMI DISTAL VOLAR RADIUS PLATE SYSTEM2Cleared 510(K)
- K033918EBI LACTOSORB GRAFT CONTAINMENT SYSTEM2Cleared 510(K)
- K040938RADIAL NAIL SYSTEM2Cleared 510(K)
- K040907ARTHREX SMALL FRAGMENT PLATES AND SCREWS2Cleared 510(K)
- K040908EBI DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K040850TSY SHOULDER PLATE IMPLANT2Cleared 510(K)
- K033303WAFER SYSTEM2Cleared 510(K)
- K040777LCP RADIAL HEAD PLATING SYSTEM2Cleared 510(K)
- K040860INTEGRA BONE FIXATION SYSTEM2Cleared 510(K)
- K040598KLS MARTIN HAND PLATING SYSTEM2Cleared 510(K)
- K040588SYNTHES (USA) 2.4 MM LCP WRIST PLATE2Cleared 510(K)
- K040593PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES2Cleared 510(K)
- K040112TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE2Cleared 510(K)
- K040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM2Cleared 510(K)
- K031961INION OTPS BIODEGRADABLE MESH PLATING SYSTEM2Cleared 510(K)
- K033756VOLAR RADIUS PLATE WITH ANGULAR STABILITY2Cleared 510(K)
- K030877TRIMED RADIAL BULLET2Cleared 510(K)
- K033456EVOLVE RADIAL PLATE2Cleared 510(K)
- K033669SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)2Cleared 510(K)
- K033519CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET2Cleared 510(K)
- K031493GROWTH GUIDANCE PLATE2Cleared 510(K)
- K031666ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS2Cleared 510(K)
- K032559SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS2Cleared 510(K)
- K032413KLS-MARTIN STERNAL PLATING SYSTEM2Cleared 510(K)
- K032187ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM2Cleared 510(K)
- K032269SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES2Cleared 510(K)
- K032032SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES2Cleared 510(K)
- K031677SYNTHES (USA) CALVICLE HOOK PLATE2Cleared 510(K)
- K031609SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM2Cleared 510(K)
- K031334TEXAS T - PLATE2Cleared 510(K)
- K031178SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES2Cleared 510(K)
- K030310SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM2Cleared 510(K)
- K030909AAP ACROPLATE2Cleared 510(K)
- K030881AVANTA CARPAL FUSION PLATING SYSTEM2Cleared 510(K)
- K030858SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS2Cleared 510(K)
- K030198HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM2Cleared 510(K)
- K030597SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES2Cleared 510(K)
- K023879SMALL TITANIUM WRIST FUSION PLATE2Cleared 510(K)
- K023802SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM2Cleared 510(K)
- K023007DISTAL RADIUS FRACTURE REPAIR SYSTEM2Cleared 510(K)
- K022139HIP TOOL IMPLANT2Cleared 510(K)
- K022515BIOMET CALCANEAL PLATE2Cleared 510(K)
- K022324NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM2Cleared 510(K)
- K022231NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM2Cleared 510(K)
- K022230NORMED MINI EXTERNAL FIXATOR SYSTEM2Cleared 510(K)
- K022325NORMED TITANIUM OSTEOTOMY PLATING SYSTEM2Cleared 510(K)
- K022323NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM2Cleared 510(K)
- K021626HALLU PLATES2Cleared 510(K)
- K022255MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES2Cleared 510(K)
- K021458SYNTHES IN-SITU BENDER/CUTTER2Cleared 510(K)
- K021321WRIST FUSION PLATE2Cleared 510(K)
- K021164MACROPORE OS TRAUMA2Cleared 510(K)
- K020872SYNTHES 3.5 MM BROAD LC-DCP PLATES2Cleared 510(K)
- K020602SYNTHES PILON PLATE2Cleared 510(K)
- K020401SYNTHES CALCANEAL PLATE2Cleared 510(K)
- K020819DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K020221IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET2Cleared 510(K)
- K020611UNIVERSAL BONE PLATE III SYSTEM (UBP III)2Cleared 510(K)
- K014197SYNTHES HIGH TIBIAL OSTEOTOMY PLATE2Cleared 510(K)
- K014155OPENING/CLOSING WEDGE OSTETOMY PLATES2Cleared 510(K)
- K013415SYNTHES ANKLE ARTHRODESIS PLATE2Cleared 510(K)
- K013775TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM2Cleared 510(K)
- K011139LORENZ LACTOSORB PANELS AND FASTENERS2Cleared 510(K)
- K013248SYNTHES LCP DISTAL TIBIA PLATES2Cleared 510(K)
- K013657MODIFICATION TO: BIOMET HUMERAL CABLE PLATES2Cleared 510(K)
- K012655CONGRUENT BONE PLATE SYSTEM2Cleared 510(K)
- K012114SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K012162STRYKER PLATING SYSTEM BASIC FRAGMENT SET2Cleared 510(K)
- K011978SYNTHES LCP PROXIMAL TIBIA PLATE2Cleared 510(K)
- K011460WUJIN #3 TIBIAL BONE PLATE2Cleared 510(K)
- K011459WUJIN #3 FEMORAL BONE PLATE2Cleared 510(K)
- K011354HIGH TIBIAL OSTEOTOMY PLATING SYSTEM2Cleared 510(K)
- K011334SYNTHES CURVED RECONSTRUCTION PLATE2Cleared 510(K)
- K011335SYNTHS ONE-THIRD TUBULAR DCL PLATE2Cleared 510(K)
- K011118NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM2Cleared 510(K)
- K011076LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW2Cleared 510(K)
- K011170SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE2Cleared 510(K)
- K003788SYNTHES RESORABLE MESHES AND SHEETS2Cleared 510(K)
- K011237LACTOSORB PLATES, MESHES, AND PANELS/SHEETS2Cleared 510(K)
- K002775DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM2Cleared 510(K)
- K002184COD COMPRESSION OSTEOTOMY DEVICE2Cleared 510(K)
- K002486PRECIMED TRAUMA SYSTEM2Cleared 510(K)
- K003235PE.R.I. II KNEE FRACTURE SYSTEM2Cleared 510(K)
- K002361SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM2Cleared 510(K)
- K002710MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)2Cleared 510(K)
- K001945SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES2Cleared 510(K)
- K001941SYNTHES MODULAR FOOT SYSTEM2Cleared 510(K)
- K984390LACTOSORB PANELS AND FASTENERS2Cleared 510(K)
- K994158MACROSORBOS PROTECTIVE SHEET2Cleared 510(K)
- K001311SYNTHES (USA) ORIBITAL MESH PLATES2Cleared 510(K)
- K000636STRYKER TRAUMA PLATING SYSTEM2Cleared 510(K)
- K000066SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM2Cleared 510(K)
- K994061LOCON-T DISTAL RADIAL PLATE2Cleared 510(K)
- K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE2Cleared 510(K)
- K992355LACTOSORB TRAUMA PLATING SYSTEM2Cleared 510(K)
- K993106SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)2Cleared 510(K)
- K993510MODIFIED BMP TROCHANTERIC PLATES2Cleared 510(K)
- K992961LORENZ SMALL FRAGMENT SYSTEM2Cleared 510(K)
- K991873KMI WRIST FUSION SYSTEM2Cleared 510(K)
- K991763LACTOSORB HAND SYSTEM2Cleared 510(K)
- K990596DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM2Cleared 510(K)
- K990392DEPUY ACE SPIDER PLATE2Cleared 510(K)
- K990481ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM2Cleared 510(K)
- K990094KMI WRIST FUSION SYSTEM2Cleared 510(K)
- K983988SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE2Cleared 510(K)
- K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEM2Cleared 510(K)
- K984458DEPUY ACE SPIDER PLATE2Cleared 510(K)
- K983853DEPUY ACE TIMAX META PLATE2Cleared 510(K)
- K983967PEDIATRIC CANNULATED OSTEOTOMY PLATES2Cleared 510(K)
- K983881COBRA EXTERNAL FIXATOR2Cleared 510(K)
- K983419HOFFMANN II MIAMI POST2Cleared 510(K)
- K982531HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K982982MINI-FIXATOR FOR COLLES FRACTURES2Cleared 510(K)
- K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)2Cleared 510(K)
- K982553OSTEO COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K982483DEPUY MOTECH PEAK FIXATION SYSTEM2Cleared 510(K)
- K982347DEPUY ACE TIMAX PILON PLATE2Cleared 510(K)
- K972913MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)2Cleared 510(K)
- K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE2Cleared 510(K)
- K981715DISTAL RADIUS FRACTURE FIXATION PLATE2Cleared 510(K)
- K981789LORENZ PECTUS SUPPORT BAR STABILIZER2Cleared 510(K)
- K981283ROGACHEFSKY DISTAL RADIUS PLATES2Cleared 510(K)
- K973812ARTHREX PUDDU OSTEOTOMY SYSTEM2Cleared 510(K)
- K980368DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM2Cleared 510(K)
- K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES2Cleared 510(K)
- K974603PLAQUAGRAFE, AGRAFE P4V2Cleared 510(K)
- K974289EPI-UNION PLATING SYSTEM2Cleared 510(K)
- K974309LACTOSORB PANELS2Cleared 510(K)
- K974030CARPAL ENGAGING WRIST FUSION PLATE2Cleared 510(K)
- K974017TIMESH SYSTEM2Cleared 510(K)
- K973982ORBITAL RECONSTRUCTION PLATES2Cleared 510(K)
- K973438OSTEO BOS SYSTEM PRODUCT LINE EXTENSION2Cleared 510(K)
- K972219ORTHOPEDIC PLATE SYSTEM2Cleared 510(K)
- K973204OSTEO BOS SYSTEM IN STAINLESS STEEL2Cleared 510(K)
- K972479ALTA PLATING SYSTEM2Cleared 510(K)
- K972323OSTEO BOS SYSTEM2Cleared 510(K)
- K972223BONE PLATE WITH CABLES2Cleared 510(K)
- K972196OSTEO ANATOMICAL BONE PLATES2Cleared 510(K)
- K971870LACTOSORB TRAUMA PLATING SYSTEM2Cleared 510(K)
- K972420LORENZ PECTUS SUPPORT BAR2Cleared 510(K)
- K961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES2Cleared 510(K)
- K971321OSTEO COMPRESSION CONDYLE SCREW SYSTEM2Cleared 510(K)
- K970258FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES2Cleared 510(K)
- K971297CENTRE-DRIVE DRILL-FREE SCREW2Cleared 510(K)
- K970503DEPUY ACE TROCHANTERIC SIDE PLATE2Cleared 510(K)
- K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM2Cleared 510(K)
- K963700METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM2Cleared 510(K)
- K963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS2Cleared 510(K)
- K961498RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)2Cleared 510(K)
- K964362KINAMED PROFIX SYSTEM2Cleared 510(K)
- K962894SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM2Cleared 510(K)
- K963798SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM2Cleared 510(K)
- K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM2Cleared 510(K)
- K961497PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM2Cleared 510(K)
- K961496R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM2Cleared 510(K)
- K942032PLAMP, PLAMP PLATE, PLAMP WITH HOOK2Cleared 510(K)
- K961485FOREFOOT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K960988LACTOSORB TRAUMA PLATING SYSTEM2Cleared 510(K)
- K955472ACE HUMERUS & RADIUS PLATES2Cleared 510(K)
- K954963SCHUHLI IMPLANT SYSTEM2Cleared 510(K)
- K953644VOLAR DISTAL RADIUS PLATE2Cleared 510(K)
- K955729LACTOSORB TRAUMA PLATING SYSTEM2Cleared 510(K)
- K952766RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)2Cleared 510(K)
- K953714ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE2Cleared 510(K)
- K943986LINK ENDO MODEL REVISION CUP2Cleared 510(K)
- K932352ORTHOPEDIC BONE PLATE2Cleared 510(K)
- K951415LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW2Cleared 510(K)
- K945139LUHR TITANIUM PAN FIXATION SYSTEM2Cleared 510(K)
- K945137LUHR TITANIUM ALLOY PAN FIXATION SYSTEM2Cleared 510(K)
- K946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM2Cleared 510(K)
- K944856ORTHOMET ACETABULAR ROOF REINFORCEMENT RING2Cleared 510(K)
- K950618ACE SUPRACONDYLAR PLATE2Cleared 510(K)
- K942359BONE PLATE SYSTEM2Cleared 510(K)
- K950105LUHR(R) TITANIUM ALLOY BURR HOLE COVERS2Cleared 510(K)
- K950115LUHR(R) TITANIUM BURR HOLE COVERS2Cleared 510(K)
- K943853DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM2Cleared 510(K)
- K936233PELVIC RADIUS PLATE2Cleared 510(K)
- K930480VARIABLE ANGULAR HOLD BONE PLATE SYSTEM2Cleared 510(K)
- K931690SPOON PLATE2Cleared 510(K)
- K934614MINI FRAGMENT PLATE2Cleared 510(K)
- K931692T-PLATE2Cleared 510(K)
- K931684EPIPHYSIS PLATE2Cleared 510(K)
- K931689SMALL STRAIGHT PLATE2Cleared 510(K)
- K931688SEMI-TUBULAR PLATE2Cleared 510(K)
- K931687MULTIPLE FRAGMENT PLATE2Cleared 510(K)
- K931685FOREARM SELF COMPRESSION PLATE2Cleared 510(K)
- K9316941/4 TUBULAR PLATE2Cleared 510(K)
- K931691STRAIGHT MINI-PLATE2Cleared 510(K)
- K931683CLOVERLEAF PLATE2Cleared 510(K)
- K931679BUTTRESS PLATE2Cleared 510(K)
- K9316931/3 TUBULAR PLATE2Cleared 510(K)
- K930966BAUMER PLATES2Cleared 510(K)
- K935448LUHR MINI BONE SCREW AND Z PLATE2Cleared 510(K)
- K933112ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES2Cleared 510(K)
- K931244BONE PLATE2Cleared 510(K)
- K930592ACE UNIVERSAL RECONSTRUCTION PLATE2Cleared 510(K)
- K925571OTI EUROPEAN COMPRESSION SYSTEM2Cleared 510(K)
- K925500ALPHATEC 130 COMPRESSION HIP SCREW2Cleared 510(K)
- K923861LUHR PAN FIXATION SYSTEM2Cleared 510(K)
- K921338ANSPACH MINI-PLATING SYSTEM2Cleared 510(K)
- K924085RECONSTRUCTION PLATE SYSTEM2Cleared 510(K)
- K922525DALL MILES BROAD BONE PLATE2Cleared 510(K)
- K922167ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES2Cleared 510(K)
- K920738ACE 100 DEGREES TUBULAR PLATE2Cleared 510(K)
- K921458TMP MICROPLATING SYSTEM2Cleared 510(K)
- K921622ALPHATEC COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K914998MICROAIRE(R) FACIAL BONE PLATING SYSTEM2Cleared 510(K)
- K914804RADIUS OSTEOTOMY PLATES2Cleared 510(K)
- K914803SCHWABE RADIUS PLATES2Cleared 510(K)
- K915315AAP BONE PLATE2Cleared 510(K)
- K915818SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE2Cleared 510(K)
- K913355LUHR PAN FIXATION SYSTEM2Cleared 510(K)
- K913271OSTEO BONE PLATED2Cleared 510(K)
- K913930FIXATION DEVICES AND BONE PLATE2Cleared 510(K)
- K912932SYNTHES MAXILLOFACIAL TITANIUM MICRO SET2Cleared 510(K)
- K912936MAY HUMERUS PLATES2Cleared 510(K)
- K913289MASTERPIECES(TM)/MICRO/MINI SYSTEMS2Cleared 510(K)
- K910482ALTA CHANNEL PLATE CONNECTOR2Cleared 510(K)
- K910957MASTERPIECES MICRO SYSTEM2Cleared 510(K)
- K905024TMP MANDIBULAR COMPRESSION SYSTEM2Cleared 510(K)
- K910175FIXATION DEVICES AND BONE PLATE2Cleared 510(K)
- K905774THACKRAY TITANIUM MINI-PLATING SYSTEM2Cleared 510(K)
- K905595ACE RECONSTRUCTIVE PLATE2Cleared 510(K)
- K903697HAWAIIAN SUPRACONDYLAR PLATE2Cleared 510(K)
- K905355BROAD SELF-COMPRESSING PLATE2Cleared 510(K)
- K895243BARNES FEMORAL LENGTHENING DEVICE2Cleared 510(K)
- K903252BROAD SELF-COMPRESSING PLATE2Cleared 510(K)
- K893201BONE PLATE2Cleared 510(K)
- K892228INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM2Cleared 510(K)
- K890939DUPONT DISTAL HUMERAL NAIL2Cleared 510(K)
- K890641ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES2Cleared 510(K)
- K885250ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS2Cleared 510(K)
- K882454LUHR MICRO SYSTEM2Cleared 510(K)
- K875086ORTHOMET BONE PLATES2Cleared 510(K)
- K873005TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS2Cleared 510(K)
- K870082BONE PLATE2Cleared 510(K)
- K870388HOFFMANN LEG LENGTHENING PLATE SYSTEM2Cleared 510(K)
- K864924KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM2Cleared 510(K)
- K862254WARSAW ORTHOPEDIC BONE PLATE2Cleared 510(K)
- K860600SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION2Cleared 510(K)
- K860591ACE MULTIPLE PIN PLATE2Cleared 510(K)
- K854825LINK SMALL BONE PLATES2Cleared 510(K)
- K853709A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM2Cleared 510(K)
- K850025ORTHOPEDIC IMPLANT PLATES2Cleared 510(K)
- K850444MEC BUTRESS PLATE2Cleared 510(K)
- K850442MEC BROAD BONE PLATE2Cleared 510(K)
- K850401LETOURNEL ACETABULAR PLATE2Cleared 510(K)
- K843370IMSI/METRIPOND GRIPPER PLATE2Cleared 510(K)
- K840954DYNAMIC CONDYLAR SCREW OR D.C.S.2Cleared 510(K)
- K833865ACE BROOKER BONE PLATING SYSTEM2Cleared 510(K)
- K811244CRYOPHTHALMIC UNIT2Cleared 510(K)
- K810061CURVED SHERMAN BONE PLATE2Cleared 510(K)
- K803176INTEROOM(POWERED OPHTHALMIC TABLE)2Cleared 510(K)
- K801603POLYETHYLENE FILLED BONE PLATE2Cleared 510(K)
- K800806I.C.S. MINI & SMALL FRAGMENT SET2Cleared 510(K)
- K800502ADDITIONAL COMPONENTS KRONNER COMPRES2Cleared 510(K)
- K782123MULTIPLICITY OF PRODUCTS2Cleared 510(K)
- K770128B.G. COMPRESSION SYSTEM2Cleared 510(K)
- K761150GALLENAUGH BONE PLATES2Cleared 510(K)
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SIGNEX
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230546
- 510(k) Type
- Traditional
- Applicant
- OSTEONIC Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/11/2024
- Days to Decision
- 469 days
- Submission Type
- Summary