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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (K032641)Portland Orthopaedics Pty. , Ltd.2004-01-20
GII SPINAL FIXATION SYSTEM (K032604)Co-Ligne AG2004-01-20
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K033476)Howmedica Osteonics Corp.2004-01-20
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM (K033363)Zimmer, Inc.2004-01-16
ADVANCE DOUBLE HIGH INSERT (K033890)Wrightmedicaltechnologyinc2004-01-15
ARTHOSCOPY PUMP A115 (K033927)W.O.M. World of Medicine AG2004-01-15
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM (K033639)Acumed, LLC2004-01-15
GAMMA3 NAIL SYSTEM (K034002)Howmedica Osteonics Corp.2004-01-15
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT (K032891)Trans1, Inc.2004-01-15
SMALL BONE FIXATION SYSTEM (K033406)Hand Innovations, Inc.2004-01-15
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) (K032108)Aesculap, Inc.2004-01-15
BIODHOC (K024185)Future Medical Systems, SA2004-01-15
SCORPIO KNEE SYSTEM - TIBIAL INSERTS (K033342)Howmedica Osteonics Corp.2004-01-15
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM (K033556)Synthes (Usa)2004-01-13
THE ANSWER SCREW SUPPLEMENTATION SYSTEM (K032966)Simplicity Orthopedic Solutions, LLC2004-01-13
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM (K033312)Ebi, L.P.2004-01-13
MODIFICATION TO JET-X HA COATED HALF PINS (K033289)Smith & Nephew, Inc.2004-01-13
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM (K033286)Orthopedic Designs, Inc. (Odi)2004-01-12
PROMOS SHOULDER (K032126)Plus Orthopedics2004-01-08
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS (K031962)Implex Corp.2004-01-08
PINNACLE REVISION SYSTEM (K033338)DePuy Orthopaedics, Inc.2004-01-08
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM (K033837)Howmedica Osteonics Corp.2004-01-08
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (K033242)Imaging Therapeutics, Inc.2003-12-31
BIOANCHOR WITH DISPOSABLE DRIVER (K033804)Linvatec Corp.2003-12-31
SUBTALAR PEG IMPLANT (K033046)Nexa Orthopedics, Inc.2003-12-23
REVOLUTION SPINAL FIXATION SYSTEM (K032219)Spinal Innovations, Inc.2003-12-19
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280)Biomet, Inc.2003-12-19
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL (K032288)Orthovita, Inc.2003-12-19
GEM INSET PATELLAR COMPONENT (K032950)Kinamed, Inc.2003-12-19
MODIFICATION TO SLIM GLIDING NAIL SYSTEM (K033763)Plus Orthopedics2003-12-18
COMPRESS DISTAL FEMORAL REPLACEMENT (K031804)Biomet, Inc.2003-12-18
COAPT ENDOTINE CHIN 3.5 DEVICE (K033524)Coapt Systems, Inc.2003-12-18
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM (K033664)Centerpulse Orthopedics, Inc.2003-12-17
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) (K032358)Disc-O-Tech Medical Technologies, Ltd.2003-12-17
PALACOS R BONE CEMENT WITH GENTAMICIN (K030086)Biomet, Inc.2003-12-17
SUBTALAR ARTHRORISIS IMPLANT (K032902)Nexa Orthopedics, Inc.2003-12-15
LORENZ STERNAL CLOSURE SYSTEM (K033740)Walter Lorenz Surgical, Inc.2003-12-15
AEQUALIS SHOULDER FRACTURE SYSTEM (K032679)Tornier2003-12-15
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K033322)Medtronic Sofamor Danek2003-12-15
VERTELINK KOBRA SPINAL FIXATION SYSTEM (K032102)Vertelink Corporation2003-12-12
MBCP (K032268)Biomatlante2003-12-11
SCORPIO LOW PROFILE TIBIAL TRAY (K032829)Howmedica Osteonics Corp.2003-12-10
STRYKER SPINE MAPS SYSTEM (K032855)Howmedica Osteonics2003-12-10
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) (K033669)Smith & Nephew, Inc.2003-12-10
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT (K032812)Orthovita, Inc.2003-12-08
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET (K033519)Biomet, Inc.2003-12-05
DEPUY ASR RESURFACING FEMORAL HEADS (K032659)DePuy Orthopaedics, Inc.2003-12-04
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS (K033516)DePuy Orthopaedics, Inc.2003-12-03
Z-SERIES MODULAR TOTAL HIP SYSTEM (K032729)Osteoimplant Technology, Inc.2003-12-03
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K033635)Ebi, L.P.2003-12-03
MODIFICATION TO TELEGRAPH HUMERAL NAIL (K033510)Fournitures Hospitalieres Industrie2003-12-03
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM (K032752)R&B Surgical Solutions, LLC2003-12-03
TIE-IN TRAPEZIUM (K033529)Wrightmedicaltechnologyinc2003-12-03
MODIFICATION TO EQUATION FIXATION SYSTEM (K033495)Medtronic Sofamor Danek, Inc.2003-12-03
CAP3 BONE SUBSTITUTE MATERIAL (K033138)Etex Corp.2003-12-02
TRIHA + (K031826)Teknimed, S.A.2003-11-28
MODIFICATION TO VERSABOND BONE CEMENT (K033509)Smith & Nephew, Inc.2003-11-28
REFLECTION CONSTRAINED LINER (K033442)Smith & Nephew, Inc.2003-11-26
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS (K033411)Synthes (Usa)2003-11-26
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT (K030319)Wrightmedicaltechnologyinc2003-11-26
GROWTH GUIDANCE PLATE (K031493)University of Utah/School of Medicine2003-11-20
UCR SPINAL SYSTEM (K032739)Seaspine2003-11-20
BI-ANGULAR SHOULDER SYSTEM (K032895)Biomet, Inc.2003-11-20
CALCIGEN PSI BONE GRAFT SUBSTITUTE (K032286)Biomet Orthopedics, Inc.2003-11-20
SCORPIO NRG KNEE SYSTEM (K030978)Howmedica Osteonics Corp.2003-11-20
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS (K030958)Ortho Tec, LLC2003-11-20
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS (K031666)Arthrex, Inc.2003-11-18
DELTA SHOULDER (K021478)Depuy, Inc.2003-11-18
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (K033329)Depuy, Inc.2003-11-14
PASSMED SPINAL SYSTEM (K032094)Medicrea2003-11-14
CLICK'X MONOAXIAL SCREWS AND HOOKS (K031175)Synthes (Usa)2003-11-14
STELKAST UNICONDYLAR KNEE SYSTEM (K032824)Stelkast Company2003-11-13
NUVASIVE MESH (K032476)Nuvasive, Inc.2003-11-13
EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS (K032964)Exactech, Inc.2003-11-13
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM (K033252)Stryker Endoscopy2003-11-13
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE (K032473)Stryker Instruments2003-11-07
DYNALOK CLASSIC SPINAL SYSTEM (K033271)Medtronic Sofamor Danek2003-11-06
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS (K033034)Zimmer, Inc.2003-11-05
HOFFMANN II PELVIC CLAMP (K033145)Howmedica Osteonics Corp.2003-11-05
VITOSS-FILLED CARTRIDGE (K032130)Orthovita, Inc.2003-11-05
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM (K033071)Synthes (Usa)2003-11-05
LACTOSORB TIBIAL L-15 SCREW AND WASHER (K033233)Biomet, Inc.2003-11-05
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS (K033112)Hand Biomechanics Lab, Inc.2003-11-05
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES (K033158)Synthes (Usa)2003-11-05
PLUS PIVOT LINK UNIVERSAL SYSTEM (K032398)Spine Vision, Inc.2003-10-31
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD (K031963)Wrightmedicaltechnologyinc2003-10-31
HEDROCEL VERTEBRAL BODY REPLACEMENT (K032527)Implex Corp.2003-10-31
PROFUSION BONE VOID FILLER KIT (K031838)Biogeneration2003-10-30
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 (K030082)Richard Wolf Medical Instruments Corp.2003-10-30
GLOBAL PRESS-FIT STEM (K032385)Global Medical Co.2003-10-30
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP (K032348)Centerpulse Orthopedics, Inc.2003-10-24
ASCENSION MODULAR RADIAL HEAD (K032686)Ascension Orthopedics, Inc.2003-10-22
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS (K032559)Synthes (Usa)2003-10-22
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES (K032726)Zimmer, Inc.2003-10-22
T2 NAILING SYSTEM (K032523)Howmedica Osteonics Corp.2003-10-22
TARAS THREADED FIXATION PIN (K032532)Union Surgical, LLC2003-10-22
CONKLUSION PEDICLE SCREW SYSTEM (K031455)Signus Medical, LLC2003-10-22
INTER-OS LIMB LENGTHENER (K031875)Inter-Os Technologies2003-10-22
STS SCREW (K032682)Ortho-Pro, LLC2003-10-22
ISO-ELASTIC CERCLAGE SYSTEM (K030256)Kinamed, Inc.2003-10-21
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