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
- 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
- K243943TriMed® Compression Screws2Cleared 510(K)
- K250613SnapHammer Hammertoe Correction System2Cleared 510(K)
- K250304TITANEX Screw Systems2Cleared 510(K)
- K242896Caliber Intramedullary Fixation System2Cleared 510(K)
- K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw2Cleared 510(K)
- K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw System2Cleared 510(K)
- K242348Locking Screw,CoCrMo2Cleared 510(K)
- K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)2Cleared 510(K)
- K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)2Cleared 510(K)
- K242691OsteoCentric Technologies Cannulated Fasteners and Nuts2Cleared 510(K)
- K242671Treace Medical Concepts (TMC) Screw Fixation System2Cleared 510(K)
- K241592Arthrex VAL and VAL KreuLock™ Compression Screw System2Cleared 510(K)
- K241359Medline UNITE® MIS Foot Recon Screw System2Cleared 510(K)
- K241277OSSIOfiber® Threaded Trimmable Fixation Nail2Cleared 510(K)
- K240815Arthrex Cannulated Screw System2Cleared 510(K)
- K233008Cannulated Headless Bone Screws2Cleared 510(K)
- K240530DynaNail Mini Tapered Hybrid2Cleared 510(K)
- K233912ARIX Cannulated Screw System2Cleared 510(K)
- K233198OSSIOfiber® Threaded Trimmable Fixation Nails2Cleared 510(K)
- K231453SnapHammer Hammertoe Correction System2Cleared 510(K)
- K234040TriMed Threaded Intramedullary Nail System2Cleared 510(K)
- K231860TDM Screw System2Cleared 510(K)
- K230507Zimed Distal Medial Tibial Plate and Screw System2Cleared 510(K)
- K233396Cannulated Screw System2Cleared 510(K)
- K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension2Cleared 510(K)
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices2Cleared 510(K)
- K231649Intraosseous Fusion Device System2Cleared 510(K)
- K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L2Cleared 510(K)
- K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System2Cleared 510(K)
- K231819Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw2Cleared 510(K)
- K223468Nexis® compressive screws2Cleared 510(K)
- K231236IBS-B MIS Beveled Screw System2Cleared 510(K)
- K230945Forma Medical Headless Compression Screw2Cleared 510(K)
- K230595OsteoCentric ACL Fixation System2Cleared 510(K)
- K230867Bone Bolt System2Cleared 510(K)
- K230397Cut Screw - Percutaneous Compression Screw2Cleared 510(K)
- K230744Acumed Acutrak 3 Headless Compression Screw System2Cleared 510(K)
- K230908Hand Trauma Threaded Nail System2Cleared 510(K)
- K230053SimpliFix Hip System2Cleared 510(K)
- K230749TriMed Threaded Intramedullary Nail System2Cleared 510(K)
- K223392REVCON (TM) Screw System2Cleared 510(K)
- K221645PROstep(TM) MIS 5mm Chamfer Screw System2Cleared 510(K)
- K230118Bony Trauma Extremity System (BTES) Screw Range, NX Nail2Cleared 510(K)
- K223761OIC Intramedullary Screw System2Cleared 510(K)
- K223847CREED™ Cannulated Screws2Cleared 510(K)
- K222799Haymaker® Screw System2Cleared 510(K)
- K221090Metal Cannulated Screw2Cleared 510(K)
- K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional2Cleared 510(K)
- K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm2Cleared 510(K)
- K223184Phantom Metatarsal Shortening System2Cleared 510(K)
- K222820BRM TOOL Screws, BIOPLAN Subtalar Implant2Cleared 510(K)
- K221342REDEMPTION Beaming System2Cleared 510(K)
- K220921Metal Bone Screw2Cleared 510(K)
- K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws2Cleared 510(K)
- K222564Treace Medical Concepts (TMC) Hammertoe Fixation System2Cleared 510(K)
- K221610Nextra CH Cannulated Hammertoe System2Cleared 510(K)
- K222505CurvaFix IM System2Cleared 510(K)
- K220359Tandry Compression Screw System2Cleared 510(K)
- K220839Arthrex Compression FT Pins2Cleared 510(K)
- K222409CAPTIVATE® Compression Screws2Cleared 510(K)
- K213614Cannulated Screws2Cleared 510(K)
- K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System2Cleared 510(K)
- K220723Hand Trauma Screw System2Cleared 510(K)
- K220892ExsoMed INnate NanoTM Lag Screw System2Cleared 510(K)
- K210146Cannulated Compression Device System2Cleared 510(K)
- K220511Medline UNITE IM Fibula Implant2Cleared 510(K)
- K212755SIGNUS SACRONAIL® Transsacral Stabilization System2Cleared 510(K)
- K203335MectaScrew Extension2Cleared 510(K)
- K211628MIS Precision Chevron Bunion System2Cleared 510(K)
- K213572JuniOrtho Plating System™2Cleared 510(K)
- K203773BRM TOOL Screws2Cleared 510(K)
- K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System2Cleared 510(K)
- K203595DynaFuse Fixation System2Cleared 510(K)
- K212547Quick-Start Screws2Cleared 510(K)
- K211770R3ACT Stabilization System2Cleared 510(K)
- K213596OSSIOfiber Compression Screw, 3.5mm2Cleared 510(K)
- K213301InCore Subtalar System2Cleared 510(K)
- K213530Nextra CH Cannulated Hammertoe System2Cleared 510(K)
- K213421Vector® Hammertoe Correction System2Cleared 510(K)
- K212996Sterile PHALINX Hammertoe System2Cleared 510(K)
- K202326BESPA Charcot System2Cleared 510(K)
- K213036Treace Medical Concepts (TMC) Screw Fixation System2Cleared 510(K)
- K210490ChM 4.5mm Cortical screws2Cleared 510(K)
- K211996Nexta PEEK Hammertoe Correction System2Cleared 510(K)
- K210792Auxein Nailing System2Cleared 510(K)
- K203029Auxilock Titanium Interference Screw2Cleared 510(K)
- K211783TriMed Threaded Intramedullary Nail System2Cleared 510(K)
- K211435PAO Cortical Screw2Cleared 510(K)
- K211290Cannulated Fasteners and Nuts2Cleared 510(K)
- K210159IntraLock System2Cleared 510(K)
- K211944Medline UNITE® Digital Fusion Screw System2Cleared 510(K)
- K210994Arthrex Beveled FT Screws2Cleared 510(K)
- K211261Axis Charcot Fixation System2Cleared 510(K)
- K203228DART-FIRE EDGE Cannulated Screw System2Cleared 510(K)
- K210754Cannulated Fasteners and Nuts2Cleared 510(K)
- K210268LTJ Screws and Washer2Cleared 510(K)
- K203381Dynanail Mini Hybrid2Cleared 510(K)
- K203105Inion CompressOn Screw2Cleared 510(K)
- K193497Fixone Biocomposite Interference Screw2Cleared 510(K)
- K203239Arthrex Low Profile Screws2Cleared 510(K)
- K203467WishBone Medical Plate and Screw System2Cleared 510(K)
- K200291CREED™ Cannulated Screws2Cleared 510(K)
- K203011Monster Screw System2Cleared 510(K)
- K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System2Cleared 510(K)
- K202817GEO Bone Screw System2Cleared 510(K)
- K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw System2Cleared 510(K)
- K202569Responsive Arthroscopy Interference Screw System2Cleared 510(K)
- K200987LTJ Screws and Washer2Cleared 510(K)
- K201850Vector Hammertoe Correction System2Cleared 510(K)
- K193660OSSIOfiber™ Compression Screws2Cleared 510(K)
- K201662REDUCT® Headless Compression Screw System2Cleared 510(K)
- K201556Intraosseous Fixation System2Cleared 510(K)
- K200840DuoHex CH Cannulated Hammertoe System2Cleared 510(K)
- K200226RetroFix2Cleared 510(K)
- K201430InFrame™ Cannulated Fixation System2Cleared 510(K)
- K201319Medline UNITE Jones Fracture Screw System2Cleared 510(K)
- K200124InCore MPJ System2Cleared 510(K)
- K200914Healix Compression Screw System2Cleared 510(K)
- K200259Headless Compression Screw System2Cleared 510(K)
- K191995S4 Screw System2Cleared 510(K)
- K193366T2 ICF2Cleared 510(K)
- K193491restor3d Metallic Interference Screw2Cleared 510(K)
- K192096Omnia Medical Trauma Screws2Cleared 510(K)
- K193451Titanium Interference Screws2Cleared 510(K)
- K193156Arthrex Mini Comprehensive Fixation System - 1.0mm Screws2Cleared 510(K)
- K192975Tyber Medical Trauma Screws2Cleared 510(K)
- K192974Tyber Medical Trauma Screw2Cleared 510(K)
- K192578InCore TMT System2Cleared 510(K)
- K192745DePuy Synthes Trauma Screws2Cleared 510(K)
- K192417ARIX Cannulated Screw System2Cleared 510(K)
- K191651Arthrex Nano SwiveLock Suture Anchor2Cleared 510(K)
- K190921Arthrex Low Profile Screws2Cleared 510(K)
- K191771SECURE Screw2Cleared 510(K)
- K190830TDM Screw Systems2Cleared 510(K)
- K191424Interphalangeal Joint Fusion Device Range2Cleared 510(K)
- K191342CrossRoads Screw System2Cleared 510(K)
- K190970PROSTEP™ TBI™ (Tailors Bunion Implant) System2Cleared 510(K)
- K191289Bone Screw Line Addition2Cleared 510(K)
- K191817ActivOrtho Continuous Compression Screw System2Cleared 510(K)
- K190324OrthoPediatrics Cannulated Screw System2Cleared 510(K)
- K183363Treace Medical Concepts (TMC) Snap-Off Screw System2Cleared 510(K)
- K183104Mini Cannulated Headed and Headless Screw Set2Cleared 510(K)
- K190231InCore® Lapidus Sterile Kits2Cleared 510(K)
- K182342IntraLock Lapidus System2Cleared 510(K)
- K183395Arthrex 2.5 mm Tenodesis Screw2Cleared 510(K)
- K190586Monster® Screw System2Cleared 510(K)
- K183628Arthrex TensionLoc System2Cleared 510(K)
- K190430OsteoCentric Bone Plate and Screw System2Cleared 510(K)
- K183026Wright Jones Fracture System2Cleared 510(K)
- K183603INnate Cannulated Screw System2Cleared 510(K)
- K181610ActivOrtho Nitinol Compression Screw System2Cleared 510(K)
- K180050CurvaFix Intramedullary Rodscrew System2Cleared 510(K)
- K183055Vector Hammertoe Correction System2Cleared 510(K)
- K182677DynaNail Mini2Cleared 510(K)
- K190035Biomet Headless Compression and Twist-Off Screws2Cleared 510(K)
- K182955EZStart Interference Screw2Cleared 510(K)
- K181377PROSTEP MICA Screw System2Cleared 510(K)
- K182989AURORA™ Screw System2Cleared 510(K)
- K182361Arthrex Compression FT Screws2Cleared 510(K)
- K180670ICONN Campbell Interference Screw2Cleared 510(K)
- K182949Healix™ Compression Screw System2Cleared 510(K)
- K182684HammerTechTM Fixation System2Cleared 510(K)
- K180573Responsive Arthroscopy Interference Screw System2Cleared 510(K)
- K180541DePuy Synthes 2.0 mm Quick Insertion Screws2Cleared 510(K)
- K181898Two-Step Implant System2Cleared 510(K)
- K182148SILVERBACK Gorilla Plating System2Cleared 510(K)
- K180348Field Orthopaedics Micro Screw System2Cleared 510(K)
- K173556Injection Screw2Cleared 510(K)
- K180024SALVATION Midfoot Nail2Cleared 510(K)
- K180377Fracture and Correction System2Cleared 510(K)
- K180500VariAx 2 System2Cleared 510(K)
- K180932Diamond Orthopedic Bone Fixation Screws and Pins2Cleared 510(K)
- K180257InCore® Lapidus System2Cleared 510(K)
- K180753SafetyFix EasyOut System2Cleared 510(K)
- K173710MotoBAND CP Implant System2Cleared 510(K)
- K172698G-Beam Fusion Beaming System2Cleared 510(K)
- K171628HBS2 Headless Bone Screw2Cleared 510(K)
- K172383Arthrosurface Bone Screws2Cleared 510(K)
- K173286Cannulated Screw Internal Fixation System2Cleared 510(K)
- K170688PIT’Stop® implant2Cleared 510(K)
- K173135VariAx 2 System2Cleared 510(K)
- K172617Treace Medical Concepts (TMC) Compression Screw System2Cleared 510(K)
- K172213MECRON Cannulated Screw System2Cleared 510(K)
- K170056IRENE Cannulated Screw System2Cleared 510(K)
- K172596Large Screws Range2Cleared 510(K)
- K163148BePOD® Foot Screws2Cleared 510(K)
- K163710BePOD® EZ Weil Screws2Cleared 510(K)
- K162171S4 Screw System™2Cleared 510(K)
- K171558ExsoMed ITN Cannulated Screw System2Cleared 510(K)
- K171407ExsoMed ArcPhix and ExsoMed ArrowPhix2Cleared 510(K)
- K170782Medline UNITE® Snap-Off Screws2Cleared 510(K)
- K170624TalarLift STS2Cleared 510(K)
- K170038FuzeFix Screw System2Cleared 510(K)
- K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System2Cleared 510(K)
- K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System2Cleared 510(K)
- K171448Hammertoe Correction System2Cleared 510(K)
- K162874Cannulated Screws Neoortho2Cleared 510(K)
- K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw2Cleared 510(K)
- K1626852-Piece Hammertoe Correction System2Cleared 510(K)
- K170687Flower Bone Screw Set2Cleared 510(K)
- K170698ALLY(TM) Bone Screws2Cleared 510(K)
- K170021SMV Scientific Cannulated Screws2Cleared 510(K)
- K170382Arthrex Compression Screws2Cleared 510(K)
- K170594I.B.S. osteosynthesis screws2Cleared 510(K)
- K162825CAPTIVATE™ Compression Screws2Cleared 510(K)
- K170889HV Screw System2Cleared 510(K)
- K170012Foot and Hand Motion2Cleared 510(K)
- K162353MICATM Screw System2Cleared 510(K)
- K170040BePOD Cannulated Arthrodesis Screws2Cleared 510(K)
- K163303OsteoMed ExtremiFix Mid and Large Screw System2Cleared 510(K)
- K163489OrthoSolutions 'System26' Bone Screws2Cleared 510(K)
- K170350ToeMATE® Hammertoe Correction System2Cleared 510(K)
- K163038EPIC Extremity Snap-Off Screw2Cleared 510(K)
- K161894SurgTech Trauma System2Cleared 510(K)
- K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw2Cleared 510(K)
- K161334RASL Repair Kit2Cleared 510(K)
- K161904GEO Bone Screw System2Cleared 510(K)
- K161259KLS Martin Cannulated Headless Screws2Cleared 510(K)
- K1609464.0 and 6.5 Cancellous Bone Screw and Washer2Cleared 510(K)
- K161778ToeTac™ 10° Hammertoe Fixation System2Cleared 510(K)
- K161597Tyber Medical BioTy® Nanotopography Trauma Screw2Cleared 510(K)
- K160791AmorChem Titanium Porous Fixation Device2Cleared 510(K)
- K161449HammerTech Fixation System2Cleared 510(K)
- K160174I.B.S. 2.0 Osteosynthesis screw2Cleared 510(K)
- K153065The Hammertoe Correction System2Cleared 510(K)
- K161058Cannulated Screw2Cleared 510(K)
- K161539Arthrosurface Bone Screws2Cleared 510(K)
- K160169The Life Spine Subtalar Implant System2Cleared 510(K)
- K160617Large Screws Range2Cleared 510(K)
- K160427dynaMX(TM) Nitinol Compression Screw2Cleared 510(K)
- K160548MC-Subtalar(TM) II2Cleared 510(K)
- K160304OsteoBullet Compression Screw2Cleared 510(K)
- K153638Bicortical Fixation Screw & Washer Nut System2Cleared 510(K)
- K160603SMV Scientific Schanz Screws2Cleared 510(K)
- K160058Biomet Variable Pitch Compression Screw System2Cleared 510(K)
- K151708RECON system - Compression Screws2Cleared 510(K)
- K153575Tyber Medical Trauma Screw2Cleared 510(K)
- K153759SIGN Compression Screw System2Cleared 510(K)
- K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws2Cleared 510(K)
- K143596MINIARS SCREWS2Cleared 510(K)
- K151701Tenodesis screw system2Cleared 510(K)
- K153333Epic Extremity Cannulated Screw System2Cleared 510(K)
- K153338Tiger Cannulated Screw System2Cleared 510(K)
- K153154Asnis JFX System2Cleared 510(K)
- K153378Monster BITE Screw System2Cleared 510(K)
- K153180Tyber Medical MST Trauma Screw2Cleared 510(K)
- K153182SELF- COMPRESSIVE SCREW2Cleared 510(K)
- K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws2Cleared 510(K)
- K150211EzFuze Implant System2Cleared 510(K)
- K152527Integra DigiFuse Cannulated Intramedullary Fusion System2Cleared 510(K)
- K152710HammerFiX Device2Cleared 510(K)
- K150693PHIN-FX Cannulated Lag Screw System2Cleared 510(K)
- K152072CrossRoads Screw System2Cleared 510(K)
- K151838PRO-TOE Hammertoe Fixation System2Cleared 510(K)
- K151270CrossTIE Intraosseous Fixation System2Cleared 510(K)
- K151241Synchro-Medical TIGER TRACK Screw System2Cleared 510(K)
- K150871ForeFoot STP System2Cleared 510(K)
- K151146N-Force Fixation System2Cleared 510(K)
- K151418Monster Screw System2Cleared 510(K)
- K151021OsteoMed Cannulated Screw System2Cleared 510(K)
- K150981SMV Scientific Bone Screws2Cleared 510(K)
- K150376Sonoma Cancellous Bone Screw and Washer2Cleared 510(K)
- K150443ToeTac Hammertoe Fixation System2Cleared 510(K)
- K151173Biomet Microfixation RibFix Blu Thoracic Fixation System2Cleared 510(K)
- K151078Arthrex RetroFusion Screw2Cleared 510(K)
- K150126Life Spine Cannulated Screws2Cleared 510(K)
- K150772Snap-Off Self-Compressive Screw2Cleared 510(K)
- K150213Subtalar Spacer System (STS)2Cleared 510(K)
- K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium2Cleared 510(K)
- K150252PHALINX Hammertoe System2Cleared 510(K)
- K150188SMV Scientific 4.5 mm Bone Screws2Cleared 510(K)
- K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw2Cleared 510(K)
- K142776Flow-Screw2Cleared 510(K)
- K150309Extremity Medical Calcaneal Osteotomy Device2Cleared 510(K)
- K141401EASY OUT2Cleared 510(K)
- K143229Nexis osteosynthesis compressive screws2Cleared 510(K)
- K143146Nexis osteosynthesis snap-off screws2Cleared 510(K)
- K143402Extremity Medical Calcaneal Osteotomy Device2Cleared 510(K)
- K143460Cannulated Screw System2Cleared 510(K)
- K143614Arthrex Low Profile Screws2Cleared 510(K)
- K143039CrossRoads Screw System2Cleared 510(K)
- K143624Headless Compression Screw System2Cleared 510(K)
- K142057INFIX CANNULATED SCREW SYSTEM2Cleared 510(K)
- K141857CrossTie Intraosseous Fixation System2Cleared 510(K)
- K1431883.Omm Biomet Cannulated Screw System2Cleared 510(K)
- K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm2Cleared 510(K)
- K142707AIS Odontoid Fracture Fixation System2Cleared 510(K)
- K142490ProxiFuse Hammer Toe Device2Cleared 510(K)
- K142585PhaLinx Hammertoe System2Cleared 510(K)
- K130019J-SCREW COMPRESSION SCREW2Cleared 510(K)
- K142658Biomet Headless Compression and Twist-off Screws2Cleared 510(K)
- K142534HyProCure II2Cleared 510(K)
- K142442MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM2Cleared 510(K)
- K141290HELICAL RIDGE PEEK INTERFERENCE SCREW2Cleared 510(K)
- K141949CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM2Cleared 510(K)
- K141937TRIDENT FUSION IMPLANT2Cleared 510(K)
- K132912DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT2Cleared 510(K)
- K140962NORMED VARIO SUBTALAR SCREW2Cleared 510(K)
- K140891BIOMET CANNULATED SCREW SYSTEM2Cleared 510(K)
- K140952CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW2Cleared 510(K)
- K140741SALVATION BEAMS AND BOLTS SYSTEM2Cleared 510(K)
- K133662SMITH & NEPHEW CANNULATED CAPTURED SCREW2Cleared 510(K)
- K140408SALVATION OSTEOPENIC SCREW2Cleared 510(K)
- K140970ONE-PIECE PEEK FUSION IMPLANT2Cleared 510(K)
- K131920STABILIZATION SCREW2Cleared 510(K)
- K132911I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW2Cleared 510(K)
- K133636EXTREMITY MEDICAL HAMMERTOE DEVICE2Cleared 510(K)
- K133515PEEK FUSION IMPLANT2Cleared 510(K)
- K133842TYBER MEDICAL TRAUMA SCREW2Cleared 510(K)
- K140148PRO-TOE HAMMERTOE FIXATION SYSTEM2Cleared 510(K)
- K133713CHARLOTTE (TM) SNAP-OFF SCREW2Cleared 510(K)
- K132244N-FORCE FIXATION SYSTEM2Cleared 510(K)
- K140283OSTEOMED EXTREMIFUSE SYSTEM2Cleared 510(K)
- K133451FIXOS SCREW SYSTEM2Cleared 510(K)
- K130613CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM2Cleared 510(K)
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- K042584OPUS MINIMAGNUM ANCHOR WITH INSERTER2Cleared 510(K)
- K042552BIO-CORE INTERFERENCE SCREW2Cleared 510(K)
- K032830PLLA CANNULATED INTERFERENCE SCREW2Cleared 510(K)
- K041069SPIRALOK ANCHOR2Cleared 510(K)
- K041075FASTIN RC ANCHOR2Cleared 510(K)
- K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE2Cleared 510(K)
- K042778BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE2Cleared 510(K)
- K041356ARTHREX TENODESIS SCREW FAMILY2Cleared 510(K)
- K041189ARTHREX TRIMIT FAMILY2Cleared 510(K)
- K041961SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K042356SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS2Cleared 510(K)
- K041835ENDOTINE MIDFACE B 4.5 DEVICE2Cleared 510(K)
- K042310ORTHO-PRO CANNULATED BONE SCREWS2Cleared 510(K)
- K042295SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 2320202Cleared 510(K)
- K042244BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE2Cleared 510(K)
- K042030HYPROCURE SUBTALAR IMPLANT SYSTEM2Cleared 510(K)
- K041936BIOPRO SUBTALAR IMPLANT2Cleared 510(K)
- K041749SCANDIUS ACL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K041533SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS2Cleared 510(K)
- K042078ENDOTINE FOREHEAD TRIPLE DEVICE2Cleared 510(K)
- K041456SNAP-OFF SCREWS2Cleared 510(K)
- K040542SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW2Cleared 510(K)
- K031714INION TRINION BIODEGRADABLE MENISCUS SCREW2Cleared 510(K)
- K041287VILEX BONE PLATE SYSTEM2Cleared 510(K)
- K041289TALUS OF VILEX (TOV)2Cleared 510(K)
- K041274RESORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K033355LACTOSCREW SCREW ANCHOR2Cleared 510(K)
- K031939BIO-EUROLIG INTERFERENCE SCREW2Cleared 510(K)
- K040701SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS2Cleared 510(K)
- K040265LITTLE GRAFTER SCREW2Cleared 510(K)
- K040656MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW2Cleared 510(K)
- K040475MICROMAX SUTURE ANCHOR2Cleared 510(K)
- K040740ENDOTINE TRANSBLEPH DEVICE2Cleared 510(K)
- K032894OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,2Cleared 510(K)
- K032447CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED2Cleared 510(K)
- K040331SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS2Cleared 510(K)
- K040594HERCULON SOFT TISSUE REATTACHMENT SYSTEM2Cleared 510(K)
- K032717BIOCRYL RAPIDE INTERFERENCE SCREW2Cleared 510(K)
- K040356KOMPRESSOR SCREW SYSTEM2Cleared 510(K)
- K033975SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS2Cleared 510(K)
- K033792BILOK ST SCREW2Cleared 510(K)
- K033749TITANIUM CANNULATED INTERFERENCE SCREW2Cleared 510(K)
- K033639ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM2Cleared 510(K)
- K032966THE ANSWER SCREW SUPPLEMENTATION SYSTEM2Cleared 510(K)
- K033804BIOANCHOR WITH DISPOSABLE DRIVER2Cleared 510(K)
- K033524COAPT ENDOTINE CHIN 3.5 DEVICE2Cleared 510(K)
- K033740LORENZ STERNAL CLOSURE SYSTEM2Cleared 510(K)
- K032902SUBTALAR ARTHRORISIS IMPLANT2Cleared 510(K)
- K033252MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM2Cleared 510(K)
- K033233LACTOSORB TIBIAL L-15 SCREW AND WASHER2Cleared 510(K)
- K032682STS SCREW2Cleared 510(K)
- K032167BIO-INTRAFIX TIBIAL SCREW AND SHEATH2Cleared 510(K)
- K032770ENDOTINE FOREHEAD DEVICE2Cleared 510(K)
- K032098ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B2Cleared 510(K)
- K032072LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE2Cleared 510(K)
- K031945ARTHREX TRIMIT SCREW, MODEL AR-4161B2Cleared 510(K)
- K031937ALANTECH GRAFT FIXATION SCREW2Cleared 510(K)
- K031155OSTEOMED SUBTALAR IMPLANT SYSTEM2Cleared 510(K)
- K032228LORENZ 2.4 SELF DRILLING SCREWS2Cleared 510(K)
- K032224BIORCI SCREW2Cleared 510(K)
- K030302HBS HEADLESS BONE SCREW2Cleared 510(K)
- K031050PCW PERCUTANEOUS COMPRESSION WIRE2Cleared 510(K)
- K031685TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 72093182Cleared 510(K)
- K031751RAPIDFIRE SELF DRILLING SCREWS2Cleared 510(K)
- K030995MINILOK QUICKANCHOR PLUS2Cleared 510(K)
- K030900INION OTPS BIODEGRADABLE FIXATON SYSTEM2Cleared 510(K)
- K030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX2Cleared 510(K)
- K023887INION OTPS BIODEGRADABLE MINI PLATING SYSTEM2Cleared 510(K)
- K030388IMPACT SUTURE ANCHOR. MODEL 4335102Cleared 510(K)
- K023365LEFORTE SYSTEM BONE SCREW2Cleared 510(K)
- K030706EBI DYNAFIX COMPRESSION BONE SCREW2Cleared 510(K)
- K030368KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW2Cleared 510(K)
- K023192STRYKER BIOZIP SUTURE ANCHOR2Cleared 510(K)
- K024115MICROFIX QUICKANCHOR PLUS2Cleared 510(K)
- K023013STRYKER XCEL ANCHOR SYSTEM2Cleared 510(K)
- K024233KOMPRESSOR SCREW SYSTEM2Cleared 510(K)
- K024086PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM2Cleared 510(K)
- K024060MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM2Cleared 510(K)
- K023922COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-001972Cleared 510(K)
- K021233AAP CANNULATED SCREWS2Cleared 510(K)
- K022952MODULAR HEAD BONE SCREW2Cleared 510(K)
- K0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM2Cleared 510(K)
- K021351BIOSTEON CROSS PIN2Cleared 510(K)
- K023294BOSWORTH CORACO-CLAVICULAR SCREW2Cleared 510(K)
- K023021MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T2Cleared 510(K)
- K023022NUGEN FX SCREW2Cleared 510(K)
- K022234ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B2Cleared 510(K)
- K022981INION CPS 2.5/2.8 SCREW2Cleared 510(K)
- K022726STAYFUSE GT-IP2Cleared 510(K)
- K021932SYNTHES 6.5 MM CANNULATED SCREW2Cleared 510(K)
- K022647HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM2Cleared 510(K)
- K021662MAGLY 6.5MM CANNULATED SCREWS2Cleared 510(K)
- K021579MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM2Cleared 510(K)
- K021556SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW2Cleared 510(K)
- K020222WISORB MALLEOLAR SCREW2Cleared 510(K)
- K021280INION HEXALON BIODEGRADABLE ACL/PCL SCREW2Cleared 510(K)
- K021254LACTOSORB MINI INTERFERENCE SCREW2Cleared 510(K)
- K021883BIOFASTIN RC THREADED SUTURE ANCHOR2Cleared 510(K)
- K021828SMALL HAMMER TOE PIN2Cleared 510(K)
- K021832ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER2Cleared 510(K)
- K020056DUET SUTURE ANCHOR2Cleared 510(K)
- K021030TITANIUM CANNULATED INTERFERENCE SCREW2Cleared 510(K)
- K013131BIOSCREW XTRALOK2Cleared 510(K)
- K020791HBS HEADLESS BONE SCREW2Cleared 510(K)
- K020377PRE-LOADED BIOSTINGER HORNET2Cleared 510(K)
- K0200434.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B2Cleared 510(K)
- K014304BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S2Cleared 510(K)
- K020159SMITH & NEPHEW TWINFIX TI QUICK T2Cleared 510(K)
- K014243BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-40502Cleared 510(K)
- K014154VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-002Cleared 510(K)
- K014153COAPT SYSTMES ENDOTINE DEVICE2Cleared 510(K)
- K013572MITEK BIOCRYL INTERFERENCE SCREWS2Cleared 510(K)
- K020446MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM2Cleared 510(K)
- K013954LORENZ SELF DRILLING SCREWS2Cleared 510(K)
- K020352SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE2Cleared 510(K)
- K013107BIOABSORBABLE INTERFERENCE SCREW MEGAFIX2Cleared 510(K)
- K020266INION CPS BSSO SCREW2Cleared 510(K)
- K014185AOS CANNULATED BONE SCREW SYSTEM2Cleared 510(K)
- K013685PLLA CANNULATED INTERFERENCE SCREW2Cleared 510(K)
- K013903HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 22Cleared 510(K)
- K013786DRG ORTHOHEX SS BONE SCREW2Cleared 510(K)
- K013534SELF-COUNTERSINKING BONE SCREW2Cleared 510(K)
- K013890SURGICAL DYNAMICS MENISCAL STAPLE2Cleared 510(K)
- K011451REUNITE FUSION SCREW2Cleared 510(K)
- K013044SYNTHES 3.9 MM PELVIC SCREWS2Cleared 510(K)
- K012945SYNTHES 2.4 MM CANNULATED SCREW2Cleared 510(K)
- K012572SOFT TISSUE SCREW AND WASHER2Cleared 510(K)
- K012469RESORBABLE NO PROFILE SCREW AND WASHER2Cleared 510(K)
- K013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS62142Cleared 510(K)
- K012872RESORBABLE SCREW ANCHOR2Cleared 510(K)
- K012817HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED2Cleared 510(K)
- K012818HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX2Cleared 510(K)
- K012798INTEX SCREW2Cleared 510(K)
- K011821MODIFICATION TO THE I.C.O.S SCREW2Cleared 510(K)
- K011946THE SPIN SNAP-OFF SCREW2Cleared 510(K)
- K012280TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 22Cleared 510(K)
- K011102ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM2Cleared 510(K)
- K010738CANNULATED PLUS SCREW SYSTEM2Cleared 510(K)
- K0120001.5MM BONE FIXATION KIT2Cleared 510(K)
- K012001SMARTSCREW2Cleared 510(K)
- K011910IN-FAST BONE SCREW SYSTEM2Cleared 510(K)
- K010964AUTO-DRIVE LAG SCREW SYSTEM2Cleared 510(K)
- K011719PLUS CANCELLOUS BONE SCREWS2Cleared 510(K)
- K010884TITANIUM COMPRESSION ANCHOR SYSTEM2Cleared 510(K)
- K011262MODIFICATION TO THE BOLD SCREW2Cleared 510(K)
- K0107832.0/2.4 CANNULATED SCREW SYSTEM2Cleared 510(K)
- K010594DJ ORTHOPEDICS POST SCREW2Cleared 510(K)
- K010554MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A2Cleared 510(K)
- K010525ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM2Cleared 510(K)
- K010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM2Cleared 510(K)
- K010595DJ ORTHOPEDICS INTERFERENCE SCREW2Cleared 510(K)
- K003077SMARTSCREW MODEL 222006...2275102Cleared 510(K)
- K001581LACTOSORB 5.0 MM WASHER2Cleared 510(K)
- K003816ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM2Cleared 510(K)
- K002274SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW2Cleared 510(K)
- K003700SYNTHES HAMSTRING LOOP2Cleared 510(K)
- K003599SMITH & NEPHEW SUTURE ANCHOR2Cleared 510(K)
- K003641BIOLOK SCREW, BIOSTEON SCREW2Cleared 510(K)
- K002654HOWMEDICA OSTEONICS SHOULDER SCREW2Cleared 510(K)
- K0022712.4MM CORTEX SCREW, SELF-TAPPING2Cleared 510(K)
- K002070BIOLOK SCREW2Cleared 510(K)
- K993166STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM2Cleared 510(K)
- K001231THE KALIX IMPLANT2Cleared 510(K)
- K993630BIOLOK SCREW2Cleared 510(K)
- K000080ASNIS III CANNULATED SCREW SYSTEM2Cleared 510(K)
- K994382NONLINEAR TAPER LAG SCREW2Cleared 510(K)
- K994152THE LIGAMENT ANCHOR SOFT SCREW2Cleared 510(K)
- K994202ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM2Cleared 510(K)
- K993762I.CO.S SCREW2Cleared 510(K)
- K000089SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS2Cleared 510(K)
- K992396BIORCI SCREW2Cleared 510(K)
- K993975ABSOLUTE ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K991964EIS THREADED SCREW FRACTURE FIXATION2Cleared 510(K)
- K992945RCI FIXATION SCREWS (WITH ASSORTED SIZES)2Cleared 510(K)
- K991024BONE BULLET SUTURE ANCHOR2Cleared 510(K)
- K993025MODIFICATION TO BONE MULCH SCREW SYSTEM2Cleared 510(K)
- K992367EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS2Cleared 510(K)
- K992611MITEK ROTATOR CUFF QUICKANCHOR PLUS2Cleared 510(K)
- K992947CANNULATED SMARTSCREW MODELS 224540C, 224570C2Cleared 510(K)
- K992487MITEK MINI QUICKANCHOR PLUS2Cleared 510(K)
- K992106MODUS SYSTEM SELF-DRILLING SCREWS2Cleared 510(K)
- K990194BIOBUTTON2Cleared 510(K)
- K992301REUNITE SCREWS2Cleared 510(K)
- K992277STAPLETAC BONE ANCHOR SYSTEM2Cleared 510(K)
- K990770BIORC ANCHOR2Cleared 510(K)
- K991477SPIN SNAP-OFF SCREW2Cleared 510(K)
- K990454BIO-INTERFERENCE SCREW2Cleared 510(K)
- K990351BONE SCREWS2Cleared 510(K)
- K991298BONE MULCH SCREW SYSTEM2Cleared 510(K)
- K990804STAYFUSE2Cleared 510(K)
- K990776AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM2Cleared 510(K)
- K990622BOLD SCREW2Cleared 510(K)
- K991197VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P242Cleared 510(K)
- K991151VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW2Cleared 510(K)
- K990513ULTIMAX CORTICAL BONE SCREWS2Cleared 510(K)
- K990019DRG MEDIUM SCREW SYSTEM2Cleared 510(K)
- K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED2Cleared 510(K)
- K984320BIOABSORBABLE INTERFERENCE SCREWS2Cleared 510(K)
- K983592SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS2Cleared 510(K)
- K984331ODI ULTIMATE COMPRESSION HIP SCREW2Cleared 510(K)
- K970829PHUSIS ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 42404202Cleared 510(K)
- K983508OSTEO COMPRESSION CONDYLE SCREW SYSTEM2Cleared 510(K)
- K983165OSTEO 4.0MM CANNULATED SCREW SYSTEM2Cleared 510(K)
- K983006OSTEO 5.0MM CANNULATED SCREW SYSTEM2Cleared 510(K)
- K982662DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K982497ARTHROTEK INTERFERENCE SCREW2Cleared 510(K)
- K980457ENDO ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM2Cleared 510(K)
- K981187ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-60012Cleared 510(K)
- K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM2Cleared 510(K)
- K981670DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K980841RCI FIXATION SCREWS2Cleared 510(K)
- K981372SYNTHES 3.0 MM PC-FIX SYSTEM2Cleared 510(K)
- K981259OSTEO 4.0MM CANNULATED SCREW SYSTEM2Cleared 510(K)
- K980681INNOVASIVE DEVICES MENISCAL SCREW2Cleared 510(K)
- K980364HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS2Cleared 510(K)
- K980440DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW2Cleared 510(K)
- K972919BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW2Cleared 510(K)
- K974785AUTO-DRIVE BONE SCREW2Cleared 510(K)
- K974756BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS2Cleared 510(K)
- K974538MENISCAL REPAIR DEVICE2Cleared 510(K)
- K973758BIOSCREW ABSORBABLE INTERFERENCE SREW2Cleared 510(K)
- K972722ULTIMATE COMPRESSION SCREW SYSTEM2Cleared 510(K)
- K973309VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW2Cleared 510(K)
- K973810DRG LARGE SCREW SYSTEM2Cleared 510(K)
- K972217ORTHOPEDIC SCREW SYSTEM2Cleared 510(K)
- K973005THE CORIFIX LIGAMENT ANCHOR2Cleared 510(K)
- K973586SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II2Cleared 510(K)
- K972494DEPUY DUPONT ABSORBABLE SET SCREW2Cleared 510(K)
- K970912LEIBINGER SELF-DRILLING SCREW2Cleared 510(K)
- K972599ACUFEX SCREW CANNULA2Cleared 510(K)
- K972403BTI CORTICAL BONE SCREWS2Cleared 510(K)
- K972233STRYKER WEDGE INTERFERENCE SCREW SYSTEM2Cleared 510(K)
- K971800OSTEO CANNULATED SCREW SYSTEM2Cleared 510(K)
- K971654OSTEO COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K971069TWIST-OFF (TM) SCREW2Cleared 510(K)
- K971070SCARF THREAD-HEAD (TM) HEAD SCREW2Cleared 510(K)
- K97106834MM SCARF THREAD-HEAD(TM) SCREW2Cleared 510(K)
- K971778OSTEO SMALL AND MINI BONE SCREWS2Cleared 510(K)
- K970929DEPUY LOW PROFILE BONE SCREW2Cleared 510(K)
- K970549TITANIUM ALLOY BONE SCREWS2Cleared 510(K)
- K964970BIOMET BONE SCREW2Cleared 510(K)
- K9650739 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW2Cleared 510(K)
- K963937NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW2Cleared 510(K)
- K963739LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS2Cleared 510(K)
- K955733HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)2Cleared 510(K)
- K963350DEPUY MOTECH PEAK FIXATION SYSTEM2Cleared 510(K)
- K960652BIOSCREW ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K962706EZ-FIX CANNULATED SCREW SYSTEM2Cleared 510(K)
- K963192SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS2Cleared 510(K)
- K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWS2Cleared 510(K)
- K962987EZ-FIX SMALL CANNULATED SCREW SYSTEM2Cleared 510(K)
- K963398ALTA FULLY THREADED CROSS-LOCKING SCREWS2Cleared 510(K)
- K963118EXTREMITY BONE SCREW2Cleared 510(K)
- K962233TWIST-OFF SCREW2Cleared 510(K)
- K962823SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER2Cleared 510(K)
- K962236SCARF THREAD-HEAD SCREW2Cleared 510(K)
- K962779COMPRESSION SCREW2Cleared 510(K)
- K960962INTERFERENCE SCREW2Cleared 510(K)
- K960940BIOSCREW ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEM2Cleared 510(K)
- K961905MEDICINELODGE, INC. SET SCREW2Cleared 510(K)
- K962011SYNTHES 7.0/7.3 MM CANNULATED SCREWS2Cleared 510(K)
- K960692SUBTALAR MBA SYSTEM2Cleared 510(K)
- K961649ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER2Cleared 510(K)
- K961234DEPUY ADVANTAGE FIXATION SCREW SYSTEM2Cleared 510(K)
- K960704DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS2Cleared 510(K)
- K961157WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW2Cleared 510(K)
- K960533K3 BONE SCREW SYSTEM2Cleared 510(K)
- K960537K2 BONE SCREW SYSTEM2Cleared 510(K)
- K925872NORTHO BONE SCREW2Cleared 510(K)
- K955837CANNULATED PLUS HIP SCREW (STERILE)2Cleared 510(K)
- K955710J.B.S. T.T.A SCREW2Cleared 510(K)
- K954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K953350MLI INTERFERENCE SCREW2Cleared 510(K)
- K954757FIXANO D.D.S. (DOUBLE SLIDING SCREW)2Cleared 510(K)
- K945303ARTHREX BIOABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K954511GO INTRAMEDULLARY NAIL LOCKING SCREW2Cleared 510(K)
- K954330SUPER SCREW 3.5 MM2Cleared 510(K)
- K953198CORTICELLOUS BONE SCREW2Cleared 510(K)
- K953650DEPUY STAINLESS STEEL SET SCREW2Cleared 510(K)
- K9544856.5MM SOLID CANCELLOUS BONE SCREW2Cleared 510(K)
- K952460STRYKER ACL INTERFERENCE SCREW SYSTEM2Cleared 510(K)
- K952831BIOSCREW ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K951232EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM2Cleared 510(K)
- K952296SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW2Cleared 510(K)
- K952272TI. ALLOY 2.0 MM CORTEX SCREW2Cleared 510(K)
- K951389REUNION BONE SCREW SYSTEM2Cleared 510(K)
- K951656NEXMED CANCELLOUS BONE SCREWS2Cleared 510(K)
- K950875OGDEN ANCHOR2Cleared 510(K)
- K946347ABSORBABLE ACETABULAR SCREW2Cleared 510(K)
- K945525ANSPACH SUTURE ANCHOR2Cleared 510(K)
- K950833DEPUY SET SCREW2Cleared 510(K)
- K932350ORTHOPEDIC SCREW FIXATION2Cleared 510(K)
- K951493OGDEN ANCHOR2Cleared 510(K)
- K951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS2Cleared 510(K)
- K951472LMT BONE ANCHOR2Cleared 510(K)
- K951233LMT BONE ANCHOR2Cleared 510(K)
- K943806HARPOON SUTURE ANCHORS2Cleared 510(K)
- K950704K4 BONE SCREW SYSTEM2Cleared 510(K)
- K951303SFC2Cleared 510(K)
- K950652OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS2Cleared 510(K)
- K945687ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW2Cleared 510(K)
- K951304SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER2Cleared 510(K)
- K934590IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS2Cleared 510(K)
- K950250MED-SURG SUTURE WASHER2Cleared 510(K)
- K934321LINVATEC STASYS-PES FIXATION DEVICE2Cleared 510(K)
- K944330ACUTRAK PLUS FIXATION SYSTEM2Cleared 510(K)
- K945426ARTHREX CANCELLOUS SCREW AND WASHER2Cleared 510(K)
- K945236AIMS CANNULATED ACL SCREW (7MM DIAMETER)2Cleared 510(K)
- K941941BONE MULCH SCREW2Cleared 510(K)
- K945182DYONICS FIXATION SCREWS2Cleared 510(K)
- K9442136.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW2Cleared 510(K)
- K943804BONE SCREW2Cleared 510(K)
- K942341CANNULATED CANCELLOUS BONE SCREW2Cleared 510(K)
- K942340CORTICAL BONE SCREW2Cleared 510(K)
- K941866PIONEER LABORATORIES CABLE SCREW2Cleared 510(K)
- K940690PIONEER LABORATORIES BONE SCREW2Cleared 510(K)
- K943539AIMS CANNULATED ACL SCREW2Cleared 510(K)
- K943474CANNULATED BONE SCREW2Cleared 510(K)
- K934366MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER2Cleared 510(K)
- K943160INTERFERENCE SCREW2Cleared 510(K)
- K941174PIONEER LABORATORIES CABLE PIN2Cleared 510(K)
- K931155STAPLE, FIXATION BONE; SCREW FIXATION BONE2Cleared 510(K)
- K932721ARTHROTEK SET SCREW2Cleared 510(K)
- K940207TITANIUM ALLOY BONE SCREWS2Cleared 510(K)
- K933719BIOSCREW ABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K931680CANNULATED CANCELLOUS SCREW2Cleared 510(K)
- K931538AMSET(TM) CANNULATED BONE SCREW2Cleared 510(K)
- K931652ACE 6.5 MM BONE SCREW2Cleared 510(K)
- K934616CANCELLOUS BONE SCREW2Cleared 510(K)
- K934615CANCELLOUS BONE SCREW2Cleared 510(K)
- K931790CORTICAL BONE SCREW2Cleared 510(K)
- K931681CANNULATED NAVICULAR SCREW2Cleared 510(K)
- K935836BONE OR INTERFERENCE SCREW2Cleared 510(K)
- K934044ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM2Cleared 510(K)
- K932862ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW2Cleared 510(K)
- K931524FULLY THREADED ALTA CANCELLOUS BONE SCREW2Cleared 510(K)
- K934469ARTHROTEK INTERFERENCE SCREW2Cleared 510(K)
- K933738M. KUROSAKA INTERFERENCE FIXATION SCREW2Cleared 510(K)
- K933352CONCEPT CANNULATED INTEREFERENCE SCREW2Cleared 510(K)
- K932027OREGON FIXATION SYSTEM INTERFERENCE SCREW2Cleared 510(K)
- K930107AME UNIVERSAL BONE SCREW2Cleared 510(K)
- K9316656.5 MM CANCELLOUS BONE SCREW2Cleared 510(K)
- K930980INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW2Cleared 510(K)
- K931187IMPLEX ACETABULAR CUP SCREW SYSTEM2Cleared 510(K)
- K930970BAUMER SCREWS2Cleared 510(K)
- K925328ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR2Cleared 510(K)
- K923841BONE SCREWS2Cleared 510(K)
- K921481INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR2Cleared 510(K)
- K930834ACUTRACT2Cleared 510(K)
- K926579TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE2Cleared 510(K)
- K924018M3 LAG SCREW FIXATION SYSTEM2Cleared 510(K)
- K926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW2Cleared 510(K)
- K9234773.5MM UNIVERSAL COMPRESSION SCREW2Cleared 510(K)
- K922788BIOACTION LOW PROFILE SCREW SYSTEM2Cleared 510(K)
- K915424ARTHREX CANNULATED INTERFERENCE SCREW2Cleared 510(K)
- K924514ACUFEX FIXATION POST2Cleared 510(K)
- K923256ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW2Cleared 510(K)
- K922166ALPHATEC SMALL FRAGMENT SET2Cleared 510(K)
- K922322ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW2Cleared 510(K)
- K912640CONCEPT ENDOSTEAL FIXATION DEVICE2Cleared 510(K)
- K915448CORTICAL BONE SCREW2Cleared 510(K)
- K915316AAP BONE SCREW2Cleared 510(K)
- K915613BONE SCREW 3.5 MM2Cleared 510(K)
- K915124UNIVERSAL COMPRESION SCREW2Cleared 510(K)
- K913210M. KUROSAKA(TM) FIXATION SCREW2Cleared 510(K)
- K910976OREGON FIXATION SCREW2Cleared 510(K)
- K915187CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW2Cleared 510(K)
- K914004ALPHATEC CANNULATED BONE SCREWS2Cleared 510(K)
- K912598ACE CORTICAL BONE SCREW2Cleared 510(K)
- K913269OSTEO BONE SCREWS2Cleared 510(K)
- K912021MAKAR MINI CANNULATED CANCELLOUS SCREWS2Cleared 510(K)
- K913415AESCULAP TITANIUM BONE SCREWS2Cleared 510(K)
- K911768AMSET(TM) BONE SCREW2Cleared 510(K)
- K910193HUENE FIXATION SCREW2Cleared 510(K)
- K904809UNIVERSAL COMPRESSION SCREW2Cleared 510(K)
- K911398ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM2Cleared 510(K)
- K905048ACE 3.5MM CORTICAL BONE SCREW2Cleared 510(K)
- K905358CANCELLOUS SCREW2Cleared 510(K)
- K905357CORTICAL BONE SCREW (EUROPEAN STYLE)2Cleared 510(K)
- K905333U.S. TYPE CRUCIATE SLOT BONE SCREW2Cleared 510(K)
- K903811ACE CANNULATED CORTICAL BONE SCREW2Cleared 510(K)
- K903810ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW2Cleared 510(K)
- K901144LEVTECH BONE SCREW2Cleared 510(K)
- K901814MCGRATH ORTHOPAEDIC BONE SCREWS2Cleared 510(K)
- K903258HAGIE PIN2Cleared 510(K)
- K903255CORTICAL BONE SCREW (EUROPEAN STYLE)2Cleared 510(K)
- K903254U.S. TYPE CRUCIATE SLOT BONE SCREW2Cleared 510(K)
- K903253CANCELLOUS SCREW2Cleared 510(K)
- K903259KNOWLES PIN2Cleared 510(K)
- K903244LAG SCREW2Cleared 510(K)
- K901616CANNULATED INTERFERENCE SCREW SYSTEM2Cleared 510(K)
- K900132ACUFEX STERILE CANNULATED INTERFERENCE SCREW;2Cleared 510(K)
- K895711ACUFEX INTERFERENCE SCREW, STERILE2Cleared 510(K)
- K896601EXACTECH BONE SCREW2Cleared 510(K)
- K895389DEPUY (TM) TRUE COMPRESSION SCREW2Cleared 510(K)
- K896044CROSS CANCELLOUS BONE SCREW2Cleared 510(K)
- K895766ASNIS II GUIDED BONE SCREW2Cleared 510(K)
- K894719CYPRESS MEDICAL BONE SCREW & PLATES2Cleared 510(K)
- K895217CORTICAL SCREW2Cleared 510(K)
- K895218CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM2Cleared 510(K)
- K895219CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM2Cleared 510(K)
- K894124OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS2Cleared 510(K)
- K894830CYPRESS CANNULATED BONE SCREW2Cleared 510(K)
- K893512DEPUY CANNULATED BONE SCREW2Cleared 510(K)
- K892925VECSEI EXPANDING SCREW2Cleared 510(K)
- K892214REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW2Cleared 510(K)
- K882934CASF CANCELLOUS BONE SCREW, BT6502Cleared 510(K)
- K883910ACUFEX INTERFERENCE SCREW AND SCREWDRIVER2Cleared 510(K)
- K882831ACE CANCELLOUS BONE SCREW2Cleared 510(K)
- K881327STUART CANNULATED CANCELLOUS BONE FIXATION SCREW2Cleared 510(K)
- K874676INTERFERENCE SCREW2Cleared 510(K)
- K875053ACROMED CANCELLOUS BONE SCREW2Cleared 510(K)
- K875050ORTHOMET BONE SCREWS2Cleared 510(K)
- K874670ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW2Cleared 510(K)
- K874672ACE CORTICAL LAG SCREW2Cleared 510(K)
- K874130TITANIUM BONE SCREWS2Cleared 510(K)
- K874593ACE SELFTAPPING CANCELLOUS BONE SCREW2Cleared 510(K)
- K873251OMNIFIT BONE SCREW2Cleared 510(K)
- K872859ACE CANCELLOUS BONE SCREW2Cleared 510(K)
- K872738CORTICAL BONE SCREWS2Cleared 510(K)
- K872156CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM2Cleared 510(K)
- K871037CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW2Cleared 510(K)
- K870141URESIL T-SYSTEM BONE SCREWS2Cleared 510(K)
- K864633VITALLIUM HEX-DRIVE BONE SCREW SYSTEM2Cleared 510(K)
- K864626CANCELLOUS BONE SCREW2Cleared 510(K)
- K862230WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW2Cleared 510(K)
- K854336MONOFIXATEUR2Cleared 510(K)
- K860323REESE ARTHRODESIS SCREW2Cleared 510(K)
- K860017ACROMED CANCELLOUS BONE SCREW2Cleared 510(K)
- K855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P2Cleared 510(K)
- K854827LINK CORTICAL SCREWS2Cleared 510(K)
- K854826LINK CANCELLOUS SCREWS2Cleared 510(K)
- K853869TITANIUIM BONE SCREW2Cleared 510(K)
- K852026FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER2Cleared 510(K)
- K850024ORTHOPEDIC IMPLANT SCREWS2Cleared 510(K)
- K851214T-SCREW2Cleared 510(K)
- K850770INTERMEDICS BONE SCREW2Cleared 510(K)
- K831873BONE SCREW2Cleared 510(K)
- K810497BONE FIXACTION SCREW2Cleared 510(K)
- K810205MECRON CANCELLOUS CANNULATED BONE SCREWS2Cleared 510(K)
- K792205SEIDEL INTRAMEDULLARY PLUG2Cleared 510(K)
- K792022HERBERT BONE SCREW2Cleared 510(K)
- K780235ORTHOPEDIC DEVICES2Cleared 510(K)
- K770035SCREW, WADSWORTH OLECRANON2Cleared 510(K)
- 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
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231231
- 510(k) Type
- Traditional
- Applicant
- Paragon 28 Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/12/2023
- Days to Decision
- 167 days
- Submission Type
- Summary