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
- K250112FitboneTM Trochanteric2Cleared 510(K)
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur2Cleared 510(K)
- K241983Fassier-Duval Telescoping IM System2Cleared 510(K)
- K243907Affixus Tibial Nailing System - 4mm screws2Cleared 510(K)
- K243890Arthrex Intramedullary Nails2Cleared 510(K)
- K243364TRIGEN META-TAN Trochanteric Antegrade Nail2Cleared 510(K)
- K241484Atlas™ Humeral Nail System2Cleared 510(K)
- K241651Affixus Tibial and Antegrade Femoral Nailing System2Cleared 510(K)
- K234128Phantom Fibula Nail System2Cleared 510(K)
- K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System2Cleared 510(K)
- K233696DePuy Synthes Retrograde Femoral Nail Advanced System2Cleared 510(K)
- K233867Fitbone Trochanteric2Cleared 510(K)
- K232648RODEO Telescopic Nail2Cleared 510(K)
- K233910Vertex Hip Fracture Nailing System2Cleared 510(K)
- K232169FITBONE® Transport and Lengthening System2Cleared 510(K)
- K233134I.T.S. INS Proximal Femur Nail2Cleared 510(K)
- K234075Flow-Nail2Cleared 510(K)
- K231343Redemption Duo Hindfoot Nail System2Cleared 510(K)
- K232267Precice Max System2Cleared 510(K)
- K230352Tornier Humeral Nail and Tornier Long Humeral Nail2Cleared 510(K)
- K230765Precice Ankle Salvage System2Cleared 510(K)
- K231266Pediatric Nailing Platform Tibia2Cleared 510(K)
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System2Cleared 510(K)
- K230257Arthrex Intramedullary Nails2Cleared 510(K)
- K230456SGM Femoral Nail System2Cleared 510(K)
- K230512Gamma4 System2Cleared 510(K)
- K220234Precice Intramedullary Limb Lengthening System2Cleared 510(K)
- K221621Pro-X1™ Trochanteric Nailing System2Cleared 510(K)
- K221084Dyna Locking Trochanteric Nail™2Cleared 510(K)
- K221221Advanced Intramedullary Nail System2Cleared 510(K)
- K221031Arthrex DualCompression Hindfoot Fusion Nail Implant System2Cleared 510(K)
- K221021Femoral Trochanteric Nail System – Neonail2Cleared 510(K)
- K222390Flex-Thread™ Ulna Intramedullary Nail System2Cleared 510(K)
- K222309Gamma4 System2Cleared 510(K)
- K210980Smith & Nephew Intramedullary Nail Systems2Cleared 510(K)
- K221489Artemis Proximal Femoral Nail System2Cleared 510(K)
- K220659AUTOBAHN(R) EVO Femoral Nails2Cleared 510(K)
- K220679Pediatric Nailing Platform Femur2Cleared 510(K)
- K221115Flow-Nail2Cleared 510(K)
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System2Cleared 510(K)
- K203811GPC Intraheal Intramedullary Nailing System2Cleared 510(K)
- K211086The Progen™ Trochanteric Nail System2Cleared 510(K)
- K212030Flex-Thread™ Distal Fibula lntramedullary Nail System2Cleared 510(K)
- K201147Elos® Intramedullary Nailing System2Cleared 510(K)
- K210869Phantom Hindfoot TTC/TC Nail System2Cleared 510(K)
- K211292Fassier-Duval Telescopic IM System2Cleared 510(K)
- K210285Adaptable Ortho Innovations Intramedullary Nail System2Cleared 510(K)
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System2Cleared 510(K)
- K201379Artemis Proximal Femoral Nail System2Cleared 510(K)
- K203399FITBONE(R) TAA2Cleared 510(K)
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail System2Cleared 510(K)
- K202348External Remote Controller ERC 4P2Cleared 510(K)
- K202935Syntec Femoral Nail Extended System2Cleared 510(K)
- K200127TELEGRAPH® EVOLUTION Humeral Nailing System2Cleared 510(K)
- K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm2Cleared 510(K)
- K200430Precice® Ankle Salvage System2Cleared 510(K)
- K202099AOS Galileo™ Trochanteric Nail System2Cleared 510(K)
- K201830ANSER Clavicle Pin2Cleared 510(K)
- K201567Precice® Bone Transport System2Cleared 510(K)
- K200869Gamma3 System2Cleared 510(K)
- K201227Phantom® Hindfoot TTC/TC Nail System2Cleared 510(K)
- K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System2Cleared 510(K)
- K192710The Simple Locking Intramedullary (Slim) System2Cleared 510(K)
- K193617Precice® Screws2Cleared 510(K)
- K193016PRECICE Bone Transport System2Cleared 510(K)
- K200814Affixus(R) Natural Nail(R) System Humeral Nail2Cleared 510(K)
- K193308T2 Alpha Tibia Nailing System, IMN Screws System2Cleared 510(K)
- K192163TTC Phantom® Intramedullary Nail System2Cleared 510(K)
- K183666EBA One Nailing System2Cleared 510(K)
- K192312Zimmer Natural Nail System Cephalomedullary Nails2Cleared 510(K)
- K190321Pediatric Nailing PlatformFemur2Cleared 510(K)
- K191336PRECICE System2Cleared 510(K)
- K191782TTC Phantom Intramedullary Nail System2Cleared 510(K)
- K191617Syntec Tibial Nail System2Cleared 510(K)
- K191598AOS ES Retrograde Femoral Nail2Cleared 510(K)
- K191238Zimmer Guide Wire Devices2Cleared 510(K)
- K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System2Cleared 510(K)
- K181296Syntec Femoral Nail System2Cleared 510(K)
- K182170PRECICE® BONE TRANSPORT™ System2Cleared 510(K)
- K181540Estremo Citieffe Nailing System2Cleared 510(K)
- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System2Cleared 510(K)
- K183162Affixus Hip Fracture Nail2Cleared 510(K)
- K181827Affixus Natural Nail System Humeral Nail2Cleared 510(K)
- K181639Panta 2 Arthrodesis Nail System2Cleared 510(K)
- K181026OsteoBridge™ IDSF System2Cleared 510(K)
- K181640X-BOLT Hip Fracture Fixation System2Cleared 510(K)
- K172830Double Medical Femoral Nail System2Cleared 510(K)
- K181184OIC Intramedullary Nail System2Cleared 510(K)
- K173656Arthrex FibuLock Nail2Cleared 510(K)
- K181375Apex Femoral Nailing System2Cleared 510(K)
- K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System2Cleared 510(K)
- K172583OrthoPediatrics PediNail Intramedullary Platform2Cleared 510(K)
- K172699Agile Nail2Cleared 510(K)
- K180503PRECICE STRYDE System2Cleared 510(K)
- K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System2Cleared 510(K)
- K173255Talon DistalFix Humeral Nail2Cleared 510(K)
- K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt2Cleared 510(K)
- K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System2Cleared 510(K)
- K171108AUTOBAHN Nailing System2Cleared 510(K)
- K173652Piccolo Composite Nailing System2Cleared 510(K)
- K170972Apex Tibial Nailing System2Cleared 510(K)
- K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System2Cleared 510(K)
- K173129PRECICE System2Cleared 510(K)
- K172157DePuy Synthes Femoral Recon Nail System2Cleared 510(K)
- K171376DynaNail TTC Fusion System2Cleared 510(K)
- K172943Flex-Thread Fibula Pin System2Cleared 510(K)
- K163653NOVOS-NAIL Limb Lengthening System (LLS)2Cleared 510(K)
- K172628PRECICE System2Cleared 510(K)
- K163627Shotel Ankle Arthrodesis Nail System2Cleared 510(K)
- K172061PRECICE UNYTE System2Cleared 510(K)
- K172114Zimmer Natural Nail System2Cleared 510(K)
- K163589SIGN IM Nail2Cleared 510(K)
- K170169PRECICE Intramedullary Limb Lengthening System2Cleared 510(K)
- K161327SYNTEC HUMERAL NAIL SYSTEM2Cleared 510(K)
- K162927PRECICE UNYTE CoCr System2Cleared 510(K)
- K163488Flex-Thread Clavicle Pin System2Cleared 510(K)
- K170346PRECICE Intramedullary Limb Lengthening System2Cleared 510(K)
- K161371Sonoma Fifth Metatarsal Repair System2Cleared 510(K)
- K163368FITBONE TAA2Cleared 510(K)
- K163014AOS Small Bone Nailing System2Cleared 510(K)
- K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System2Cleared 510(K)
- K161264TRIGEN Low Profile Bone Screws2Cleared 510(K)
- K160545GAP ENDO-EXO MEDULLARY SYSTEM2Cleared 510(K)
- K161254Renovo Life Small Bone IM Nail System2Cleared 510(K)
- K160167DePuy Synthes TFNA Augmentation System2Cleared 510(K)
- K160325PRECICE Intramedullary Limb Lengthening System2Cleared 510(K)
- K160267PRECICE Trauma Nail System2Cleared 510(K)
- K160069Sonoma Fibula Repair System2Cleared 510(K)
- K153536Piccolo Composite® Nailing System2Cleared 510(K)
- K152370PRECICE Trauma Nail System2Cleared 510(K)
- K151062WASTON Metallic Intramedullary Nail System2Cleared 510(K)
- K150769Cardinal Health Trochanteric IM Nail System2Cleared 510(K)
- K152757SIGN Hip Construct (SHC)2Cleared 510(K)
- K152295Talon DistalFix Antegrade/Retrograde Femoral Nail2Cleared 510(K)
- K151456Small Bone Nail Implant2Cleared 510(K)
- K143245GPC Intramedullary Nailing Systems2Cleared 510(K)
- K151010Piccolo Composite Nailing System2Cleared 510(K)
- K143355The Simple Locking IntraMedullary (SLIM) System2Cleared 510(K)
- K150655OIC Intramedullary Nail System2Cleared 510(K)
- K151131PRECICE Intramedullary Limb Lengthening System2Cleared 510(K)
- K150867Affixus Tibial Nailing System2Cleared 510(K)
- K143204AOS Clavicle Intramedullary Device2Cleared 510(K)
- K143321ITST Intertrochanteric/Subtrochanteric Fixation System2Cleared 510(K)
- K150471CalcaNail Orthopedic Arthrodesis Nail2Cleared 510(K)
- K150463CalcaNail Orthopedic Nail2Cleared 510(K)
- K150656PRECICE Intramedullary Limb Lengthening System2Cleared 510(K)
- K150073MICRONAIL Distal Radius System2Cleared 510(K)
- K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System2Cleared 510(K)
- K143276Acumed Small Bone IM Nail System2Cleared 510(K)
- K142945Sonoma Fibula Repair System2Cleared 510(K)
- K142599PRECISE Trauma Nail System2Cleared 510(K)
- K141571ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM2Cleared 510(K)
- K133166INS HILDEN TIBIAL ARZZT2Cleared 510(K)
- K142602VALOR Hindfoot Fusion Nail System2Cleared 510(K)
- K142281ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM2Cleared 510(K)
- K141739RESIDUAL LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K141347EMERGE MEDICAL IM NAIL SYSTEM2Cleared 510(K)
- K141103INTRAMEDULLARY NAIL AND SCREWS-NEONAIL2Cleared 510(K)
- K141228AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW2Cleared 510(K)
- K140601FLOW-NAIL2Cleared 510(K)
- K141447PRECICE TRAUMA NAIL SYSTEM2Cleared 510(K)
- K131609DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM2Cleared 510(K)
- K141023PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K131984SYNTHES SYNSONIC ULNA NAIL2Cleared 510(K)
- K132078METALLIC INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K133104VAN HIP FRACTURE SYSTEM2Cleared 510(K)
- K132945CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL2Cleared 510(K)
- K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM2Cleared 510(K)
- K131490ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K132830DISTALOCK TIBIAL IM NAIL SYSTEM2Cleared 510(K)
- K133081TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N2Cleared 510(K)
- K132428IDEAL2Cleared 510(K)
- K133289PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT2Cleared 510(K)
- K131677PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K131365T2 TIBIAL NAILING SYSTEM2Cleared 510(K)
- K132774PICCOLO COMPOSITE NAILING SYSTEM2Cleared 510(K)
- K130595ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL2Cleared 510(K)
- K132005RETROGRADE FEMORAL NAIL2Cleared 510(K)
- K130051611 ANKLE FUSION NAIL2Cleared 510(K)
- K131005EBA2 FEMORAL NAILING SYSTEM2Cleared 510(K)
- K123810PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM2Cleared 510(K)
- K123569ANTEGRADE FEMORAL NAIL2Cleared 510(K)
- K130147ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)2Cleared 510(K)
- K122823SIGN PEDIATRIC FIN NAIL2Cleared 510(K)
- K13062512MM AND 13MM TIBIAL NAILS2Cleared 510(K)
- K123745SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL2Cleared 510(K)
- K123401GAMMA3 AND T2 RECON TARGETING DEVICES2Cleared 510(K)
- K121312INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K122170SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION2Cleared 510(K)
- K113219ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K120148AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW2Cleared 510(K)
- K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEM2Cleared 510(K)
- K120715ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT2Cleared 510(K)
- K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEM2Cleared 510(K)
- K120419DYNA LOCKING ANKLE NAIL2Cleared 510(K)
- K102577FORCE MEDICAL IM NAIL SYSTEM2Cleared 510(K)
- K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR2Cleared 510(K)
- K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )2Cleared 510(K)
- K113695ELLIPSE PRECICE TRAUMA NAIL SYSTEM2Cleared 510(K)
- K113387CITIEFFE TITANIUM NAILING SYSTEM2Cleared 510(K)
- K113828DYNANAIL ANKLE ARTHRODESIS NAIL2Cleared 510(K)
- K113409S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL2Cleared 510(K)
- K120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)2Cleared 510(K)
- K111232GAP ENDO-EXO MEDULLARY SYSTEM2Cleared 510(K)
- K113303OSLEOBRIDGE IDSF SPACER CONECTOR2Cleared 510(K)
- K111891SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS2Cleared 510(K)
- K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL2Cleared 510(K)
- K111352TALON DISTALFIX PROXIMAL FEMORAL NAIL2Cleared 510(K)
- K111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)2Cleared 510(K)
- K112059T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP2Cleared 510(K)
- K101934DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-00002Cleared 510(K)
- K101997ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM2Cleared 510(K)
- K111025TRIGEN LOW PROFILE BONE SCREW2Cleared 510(K)
- K111444UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION2Cleared 510(K)
- K111056PICCOLO COMPOSITE NAILING SYSTEM2Cleared 510(K)
- K110552VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW2Cleared 510(K)
- K110322OLECRA INTRAMEDULLARY FIXATION SYSTEM2Cleared 510(K)
- K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM2Cleared 510(K)
- K102369PICCOLO COMPOSITE NAILING SYSTEM2Cleared 510(K)
- K103533ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM2Cleared 510(K)
- K102992T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES2Cleared 510(K)
- K101939OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM2Cleared 510(K)
- K101622ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS2Cleared 510(K)
- K100112SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)2Cleared 510(K)
- K100925ASCENSION ANKLE FUSION NAIL SYSTEM2Cleared 510(K)
- K092720WRIST ARTHRODESIS NAIL SYSTEM2Cleared 510(K)
- K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG08202Cleared 510(K)
- K100497QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)2Cleared 510(K)
- K101438T2 GREATER TROCHANTER NAIL2Cleared 510(K)
- K100238HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM2Cleared 510(K)
- K092748SURESHOT TAN NAILS AND ACCESSORIES2Cleared 510(K)
- K100312DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K091425QUANTUM M COMPOSITE NAILING SYSTEM2Cleared 510(K)
- K092110WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)2Cleared 510(K)
- K092771DYNA LOCKING IM NAIL2Cleared 510(K)
- K093089MAGNUM NAIL2Cleared 510(K)
- K091309REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX2Cleared 510(K)
- K091566ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS2Cleared 510(K)
- K092646SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW2Cleared 510(K)
- K091976BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL2Cleared 510(K)
- K091788PANTA NAIL (DIA. 10MM), PANTA NAIL XL2Cleared 510(K)
- K090857VALOR ANKLE FUSION NAIL SYSTEM2Cleared 510(K)
- K090596ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM2Cleared 510(K)
- K090241SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)2Cleared 510(K)
- K083648GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL2Cleared 510(K)
- K090478AOS PROXIMAL HUMERAL NAIL2Cleared 510(K)
- K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEM2Cleared 510(K)
- K083497ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS2Cleared 510(K)
- K083458INTRAMEDULLARY FIXATION ROD (IFS)2Cleared 510(K)
- K090091OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM2Cleared 510(K)
- K082754AEQUALIS HUMERAL NAIL SYSTEM2Cleared 510(K)
- K081230TRAUSON INTRAMEDULLARY NAIL2Cleared 510(K)
- K083437MODIFICATION TO T2 RECON NAIL SYSTEM2Cleared 510(K)
- K082770ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL2Cleared 510(K)
- K082018T2 FLEXIBLE NAIL2Cleared 510(K)
- K081832ENSPLINTCMX CLAVICLE PIN2Cleared 510(K)
- K082148SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION2Cleared 510(K)
- K081452SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K081356OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM2Cleared 510(K)
- K081243BIOMET PHOENIX ANKLE NAIL SYSTEM2Cleared 510(K)
- K081152T2 FEMORAL NAIL2Cleared 510(K)
- K073402SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM2Cleared 510(K)
- K070761SANATMETAL NAILS AND PINS2Cleared 510(K)
- K071679METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS2Cleared 510(K)
- K070955ACID ETCHED LAG SCREWS2Cleared 510(K)
- K072161BIOMET FEMORAL LOCKING NAIL SYSTEM2Cleared 510(K)
- K071944ACUMED SMALL BONE LOCKING SYSTEM II2Cleared 510(K)
- K070444AOS TIBIAL NAIL2Cleared 510(K)
- K070843SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM2Cleared 510(K)
- K070294SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES2Cleared 510(K)
- K063570BIOMET TIBIAL LOCKING NAIL SYSTEM2Cleared 510(K)
- K063225METAIZEAU NAILING SYSTEM2Cleared 510(K)
- K061910SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)2Cleared 510(K)
- K051965OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM2Cleared 510(K)
- K060921S2 RECON NAIL SYSTEM2Cleared 510(K)
- K053261ORTHOFIX TITANIUM NAILING SYSTEMS2Cleared 510(K)
- K053105SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP2Cleared 510(K)
- K051678SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM2Cleared 510(K)
- K052058MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL2Cleared 510(K)
- K051590T2 ANKLE ARTHRODESIS NAIL2Cleared 510(K)
- K051624T2 RECON NAIL SYSTEM2Cleared 510(K)
- K050882NEWDEAL ANKLE NAIL2Cleared 510(K)
- K050241AOS HUMERAL NAIL2Cleared 510(K)
- K050118EBI TROCHANTERIC NAIL SYSTEM2Cleared 510(K)
- K043431GAMMA3 NAIL SYSTEM2Cleared 510(K)
- K043200SIGN FIN NAIL2Cleared 510(K)
- K043233GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL2Cleared 510(K)
- K043270SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES2Cleared 510(K)
- K043404MODIFICATION TO T2 PROXIMAL HUMERAL NAIL2Cleared 510(K)
- K042409MODULAR ARTHRODESIS NAIL2Cleared 510(K)
- K043052TRIGEN HINDFOOT FUSION NAIL2Cleared 510(K)
- K042396T2 PROXIMAL HUMERAL NAIL2Cleared 510(K)
- K042440ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM2Cleared 510(K)
- K042332TITANIUM TELEGRAPH HUMERAL NAIL2Cleared 510(K)
- K042135SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)2Cleared 510(K)
- K042325TROCHANTERIC NAIL SYSTEM2Cleared 510(K)
- K041393FASSIER-DUVAL TELSCOPIC IM SYSTEM2Cleared 510(K)
- K040929TRIGEN ADOLESCENT TAN2Cleared 510(K)
- K040336SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM2Cleared 510(K)
- K040462TRIGEN TROCHANTERIC ANTEGRADE NAIL2Cleared 510(K)
- K033878ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM2Cleared 510(K)
- K033806ACE PROXIMAL HUMERAL NAIL SYSTEM2Cleared 510(K)
- K033618SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM2Cleared 510(K)
- K034002GAMMA3 NAIL SYSTEM2Cleared 510(K)
- K033286ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM2Cleared 510(K)
- K033510MODIFICATION TO TELEGRAPH HUMERAL NAIL2Cleared 510(K)
- K033329DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS2Cleared 510(K)
- K032523T2 NAILING SYSTEM2Cleared 510(K)
- K032898T2 RECON NAIL SYSTEM2Cleared 510(K)
- K032722TRIGEN STRAIGHT HUMERAL NAIL SYSTEM2Cleared 510(K)
- K032588MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)2Cleared 510(K)
- K032548IP-XS COMPRESSION NAIL SYSTEM2Cleared 510(K)
- K032579S2 NAIL SYSTEM2Cleared 510(K)
- K032367ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL2Cleared 510(K)
- K032244GAMMA 3 NAIL SYSTEM2Cleared 510(K)
- K032097DEPUY ACE VERSANAIL TIBIAL NAIL2Cleared 510(K)
- K031438ACUMED SMALL BONE LOCKING ROD SYSTEM II2Cleared 510(K)
- K031219MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)2Cleared 510(K)
- K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEM2Cleared 510(K)
- K023241TELEGRAPH HUMERAL NAIL2Cleared 510(K)
- K023115ACE VERSANAIL2Cleared 510(K)
- K023267T2 SUPRACONDYLAR NAIL SYSTEM2Cleared 510(K)
- K023437FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL2Cleared 510(K)
- K022632SIGN IM NAIL2Cleared 510(K)
- K022481S2 TIBIAL NAIL2Cleared 510(K)
- K021786TITANIUM ANKLE ARTHRODESIS NAIL2Cleared 510(K)
- K022461S2 FEMORAL NAIL2Cleared 510(K)
- K022225VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM2Cleared 510(K)
- K021744T2 FEMORAL NAIL2Cleared 510(K)
- K021008ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL2Cleared 510(K)
- K020962G4 SLEEVED NAIL2Cleared 510(K)
- K021324FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)2Cleared 510(K)
- K020562APEX INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K020384T2 ARTHRODESIS NAIL SYSTEM2Cleared 510(K)
- K021027S2 TIBIAL NAIL2Cleared 510(K)
- K021026S2 FEMORAL NAIL2Cleared 510(K)
- K020773LONG LENGTH GAMMA NAIL2Cleared 510(K)
- K020677GAMMA 3 LAG SCREW2Cleared 510(K)
- K013923TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER2Cleared 510(K)
- K014220T2 FEMORAL NAIL SYSTEM2Cleared 510(K)
- K013563LONG TROCHANTERIC NAIL SYSTEM2Cleared 510(K)
- K013132SIGN IM NAIL2Cleared 510(K)
- K013616POLARUS CAP SCREW2Cleared 510(K)
- K013449MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM2Cleared 510(K)
- K013430ACE BIO WIN TIBIAL NAILING SYSTEM2Cleared 510(K)
- K013468LONG LENGTH DYAX NAIL2Cleared 510(K)
- K013524TROCHANTERIC DYAX NAIL SYSTEM2Cleared 510(K)
- K012967MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM2Cleared 510(K)
- K012190AOS MODULAR FEMORAL NAIL2Cleared 510(K)
- K011857SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM2Cleared 510(K)
- K012158MODIFICATION TO: LONG LENGTH GAMMA NAIL2Cleared 510(K)
- K011129SIGN IM NAIL2Cleared 510(K)
- K010988FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM2Cleared 510(K)
- K010901FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B2Cleared 510(K)
- K011622OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS2Cleared 510(K)
- K011529T2 HUMERAL NAIL SYSTEM2Cleared 510(K)
- K010780TROCHANTERIC NAIL2Cleared 510(K)
- K010322ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)2Cleared 510(K)
- K010149WUJIN #3 FEMORAL NAIL2Cleared 510(K)
- K010801T2 FEMORAL NAIL2Cleared 510(K)
- K003797ACE AIM TTC FUSION NAIL2Cleared 510(K)
- K003018TITAN TIBIAL NAIL2Cleared 510(K)
- K002783FIXION INTERLOCKING NAIL (FIXION IL NAIL)2Cleared 510(K)
- K002278BROOKER FEMORAL NAILS2Cleared 510(K)
- K002057BROOKER TIBIA NAILS2Cleared 510(K)
- K001938VECTOR TARGETING SYSTEM2Cleared 510(K)
- K992850MAGELLAN TIBIAL INTRAMEDULLARY NAIL2Cleared 510(K)
- K992856MAGELLAN HUMERAL INTRAMEDULLARY NAIL2Cleared 510(K)
- K993956TITANIUM PEDIATRIC FEMORAL NAIL2Cleared 510(K)
- K993603WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW2Cleared 510(K)
- K993670MODIFIED LONG LENGTH GAMMA NAIL2Cleared 510(K)
- K992350PYLON INTRAMEDULLAARY NAIL SYSTEM2Cleared 510(K)
- K992063OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY2Cleared 510(K)
- K991790ULTIMAX ANKLE FUSION ROD SYSTEM2Cleared 510(K)
- K990717FIXION INTRAMEDULLARY NAILING SYSTEM2Cleared 510(K)
- K990322PERRY HUMERAL NAIL2Cleared 510(K)
- K990436ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K990152OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER2Cleared 510(K)
- K984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM2Cleared 510(K)
- K984543SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 252Cleared 510(K)
- K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE2Cleared 510(K)
- K984305ZETA MULTIZONE LOCKING NAIL SYSTEM2Cleared 510(K)
- K984353OSTEO 9MM IC TIBIAL NAIL2Cleared 510(K)
- K983641HOLLAND FEMORAL NAIL SYSTEM2Cleared 510(K)
- K982958ZETA MULTIZONE LOCKING NAIL SYSTEM2Cleared 510(K)
- K983358G/K SFN AND STN LOCKING NAILS2Cleared 510(K)
- K983339OSTEO DYNATROC PROXIMAL FEMORAL NAIL2Cleared 510(K)
- K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES2Cleared 510(K)
- K982873ZETA MULTIZONE SCN LOCKING NAIL2Cleared 510(K)
- K982601OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL2Cleared 510(K)
- K982602RETROGRADE ROD SYSTEM2Cleared 510(K)
- K981309OSTEO I-C HUMERAL NAIL SYSTEM2Cleared 510(K)
- K981261HOWMEDICA SCN NAIL2Cleared 510(K)
- K981230ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K980609SEGMENTAL DEFECT REPLACEMENT SYSTEM2Cleared 510(K)
- K980102BTI HUMERAL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K974720HOWMEDICA(R) FULLY THREADED SCREWS2Cleared 510(K)
- K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL2Cleared 510(K)
- K973944ORTHOFIX FEMORAL NAILING SYTEM2Cleared 510(K)
- K972813GAMMA LOCKING NAIL SYSTEM2Cleared 510(K)
- K972811HOWMEDICA FULLY THREADED SCREWS2Cleared 510(K)
- K971056MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION2Cleared 510(K)
- K972692MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL2Cleared 510(K)
- K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL2Cleared 510(K)
- K972108ALTA INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K964444QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM2Cleared 510(K)
- K971816ATLAS FRACTURE PROXIMAL HUMERAL NAIL2Cleared 510(K)
- K971135MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM2Cleared 510(K)
- K970257FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES2Cleared 510(K)
- K970280FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES2Cleared 510(K)
- K970897BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K970202DEPUY ACE AIM TITANIUM TIBIAL NAIL2Cleared 510(K)
- K961360TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K965098INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K964163TRIMAX NAIL SYSTEM2Cleared 510(K)
- K964243HUMERUS WIRES2Cleared 510(K)
- K963026TBD2Cleared 510(K)
- K963077TBD2Cleared 510(K)
- K962561SUPRACONDYLAR INTRAMEDULLARY NAIL2Cleared 510(K)
- K962552EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K962553EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K962091POLARUS AF ROD2Cleared 510(K)
- K961027ORTHOFIX TIBIAL NAILING SYSTEM2Cleared 510(K)
- K960524ALTA CFX IM ROD SYSTEM2Cleared 510(K)
- K955761TIBIA ORTHONAIL2Cleared 510(K)
- K932330TI-6AL-7NB URTN2Cleared 510(K)
- K954756FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM2Cleared 510(K)
- K954554ALTA TIBIAL/HUMERAL ROD2Cleared 510(K)
- K953334SYNTHES FLEXNAIL2Cleared 510(K)
- K952923INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL2Cleared 510(K)
- K952739ORTHONAIL2Cleared 510(K)
- K951740INTRAMEDULARY FIXATION ROD2Cleared 510(K)
- K952534TENTATIVELY POLARUS EX ROD2Cleared 510(K)
- K951673ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2Cleared 510(K)
- K950394TIBIA-TALUS-CALCANEUS NAIL2Cleared 510(K)
- K935383FEMROD AND FEMROD RECON INSERT2Cleared 510(K)
- K933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION2Cleared 510(K)
- K944501TRUE/FLEX INTRAMEDULLARY ROD END-CAP2Cleared 510(K)
- K935295ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION2Cleared 510(K)
- K933340OSTEO INTERLOCKING-COMPRESSION NAIL2Cleared 510(K)
- K930972INTRAMEDULLARY SYSTEMS2Cleared 510(K)
- K934962AIM SUPRACONDYLAR NAIL2Cleared 510(K)
- K934643ACE HUMERAL NAIL2Cleared 510(K)
- K933518SYNTHES UNREAMED HUMERAL NAIL (URHN)2Cleared 510(K)
- K932593ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL2Cleared 510(K)
- K934148TRUE/FLEX CLAVICLE RODS2Cleared 510(K)
- K933361ACUMED RADIUS ROD2Cleared 510(K)
- K933027THE MODULAR NAIL2Cleared 510(K)
- K931256SEIDEL HUMERAL LOCKING NAIL2Cleared 510(K)
- K926232ALTA CFX ROD SYSTEM2Cleared 510(K)
- K926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM2Cleared 510(K)
- K925544SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS2Cleared 510(K)
- K923580SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL2Cleared 510(K)
- K923597SYNTHES TITANIUM UNREAMED FEMORAL NAIL2Cleared 510(K)
- K924656TRUE/ FLEX FIBULA RODS2Cleared 510(K)
- K922266ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES2Cleared 510(K)
- K920666INTRAMEDULARY FIXATION ROD2Cleared 510(K)
- K922195OSTEO FEMORAL NAIL2Cleared 510(K)
- K922196OSTEO TIBIA NAIL2Cleared 510(K)
- K920598TRUE/FLEX HUMERUS CAP2Cleared 510(K)
- K915435INTERLOCKING TIBIAL NAILING SYSTEM2Cleared 510(K)
- K913949TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS2Cleared 510(K)
- K912930INTERLOCKING FEMORAL NAILING SYSTEM2Cleared 510(K)
- K912710TRUE/FLEX TIBIAL RODS WITH CAP2Cleared 510(K)
- K912420ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM2Cleared 510(K)
- K911554AIM TIBIAL NAIL2Cleared 510(K)
- K903526ALTA(R) PFX IM ROD2Cleared 510(K)
- K903256HANSEN-STREET TYPE INTRAMEDULLARY NAIL2Cleared 510(K)
- K902264TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY2Cleared 510(K)
- K893377RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS2Cleared 510(K)
- K890936ALTA HOLLOW TIBIAL RODS2Cleared 510(K)
- K884500ALTA NON-REAMED TIBIAL ROD2Cleared 510(K)
- K884610INTERLOCKING INTRAMEDULLARY NAILS2Cleared 510(K)
- K884407TRACER SKELETAL TRACTION PINS2Cleared 510(K)
- K882443ZINDRICK IM ROD INSTRUMENTS2Cleared 510(K)
- K880737SELF GUIDING (SG) INTERLOCKING NAIL2Cleared 510(K)
- K871539ZINDRICK IM ROD2Cleared 510(K)
- K871947MODIFIED HUCKSTEP INTRAMEDULLARY NAIL2Cleared 510(K)
- K871814SARMIENTO FOREARM NAIL2Cleared 510(K)
- K871872HI MARC INTERLOCKING NAIL2Cleared 510(K)
- K871608RODRIGUEZ NAIL2Cleared 510(K)
- K870040INTRAMEDULLARY NAIL2Cleared 510(K)
- K861365FASICULATED NAIL2Cleared 510(K)
- K860756GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD2Cleared 510(K)
- K860592ACE IM ROD2Cleared 510(K)
- K853250FEMOROTIBIAL MEDULLARY NAIL2Cleared 510(K)
- K854227FASCILULATED NAIL2Cleared 510(K)
- K854338KIRSCHNER INTRAMEDULLARY NAIL SYSTEM2Cleared 510(K)
- K852020INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI2Cleared 510(K)
- K850441MEC INTRAMEDULLARY ROD2Cleared 510(K)
- K850142ACE INTRAMEDULLARY ROD FOR SMALL BONES2Cleared 510(K)
- K830087INTRAMEDULLARY ROD2Cleared 510(K)
- K820852MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY2Cleared 510(K)
- K813371GROSSE AND KEMPF LOCKING NAIL SYS.2Cleared 510(K)
- K811002ENDER PINS2Cleared 510(K)
- K810956MARCOVE HUMERAL ROD2Cleared 510(K)
- K810957MARCOVE INTRAMEDULLARY ROD2Cleared 510(K)
- K810535MOURADIAN MODIFIED ZICKEL HUMERAL ROD2Cleared 510(K)
- K803106AGINSKY NAIL2Cleared 510(K)
- K803196FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM2Cleared 510(K)
- K801010KIRSCHNER WIRE2Cleared 510(K)
- K792203CURVED KUNTSCHER INTRAMEDULLARY NAIL2Cleared 510(K)
- K772081NAIL, INTRAMEDULLARY, FLEXIBLE2Cleared 510(K)
- 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
- 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
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213328
- 510(k) Type
- Traditional
- Applicant
- Stryker GmbH
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/11/2022
- Days to Decision
- 129 days
- Submission Type
- Summary