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Orthopedic

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

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RecordFirmDate
U2 HIP STEM, TI POROUS COATED (K003237)United Orthopedic Corp.2001-01-10
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B (K003227)Arthrex, Inc.2001-01-08
ISOLA CLOSED DUAL ROD CONNECTOR (K003822)Depuyacromed2001-01-08
VERTEBRAL BODY REPLACEMENT (K003155)Osteotech, Inc.2001-01-04
UNICONDYLAR INTERPOSITIONAL SPACER (K003269)Sulzer Orthopedics, Inc.2001-01-04
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM (K003832)Sulzer Orthopedics, Inc.2001-01-04
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K003898)Ebi, L.P.2001-01-04
MODIFICATION TO EBI SPINELINK SYSTEM (K003764)Ebi, L.P.2001-01-02
BIOMET EXTERNAL WRIST PLATE (K003240)Biomet, Inc.2000-12-29
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003212)Disco-O-Tech Medical Technologies, Ltd.2000-12-28
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003215)Disco-O-Tech Medical Technologies, Ltd.2000-12-27
CD HORIZON SPINAL SYSTEM (K000641)Medtronic Sofamor Danek, Inc.2000-12-22
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM (K003728)Tornier2000-12-20
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM (K002923)Howmedica Osteonics Corp.2000-12-18
TRANSFX ANGLED RODS (K003205)Immedica, Inc.2000-12-15
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS (K002747)Smith & Nephew, Inc.2000-12-15
M2A 32MM TAPER SYSTEM (K003363)Biomet, Inc.2000-12-15
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K002733)Depuyacromed2000-12-15
TITAN TIBIAL NAIL (K003018)Howmedica Osteonics Corp.2000-12-15
PROTRACT PRESS FIT HIP STEM (K003447)Stelkast Company2000-12-15
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING (K003211)Howmedica Osteonics Corp.2000-12-15
ACE AIM TTC FUSION NAIL (K003797)DePuy Orthopaedics, Inc.2000-12-15
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (K994337)Orthovita Co.2000-12-14
COPELAND RESURFACING HEADS (K003044)Biomet, Inc.2000-12-13
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K003523)DePuy Orthopaedics, Inc.2000-12-13
ORTHOMATRIX, INC. CERCLAGE SYSTEM (K001254)Orthomatrix, Inc.2000-12-13
PRO-FEMUR R (K003016)Wrightmedicaltechnologyinc2000-12-13
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 (K002960)Zimmer, Inc.2000-12-11
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP (K994146)Plus Orthopedics2000-12-11
TRIDENT ALL POLY CUP (K001956)Howmedica Osteonics Corp.2000-12-11
SYNERGY HA COATED POROUS FEMORAL STEMS (K002996)Smith & Nephew, Inc.2000-12-11
VERSABOND BONE CEMENT (K001160)Smith & Nephew, Inc.2000-12-11
OPUS ROD FIXATION SYSTEM (K003490)Howmedica Osteonics Corp.2000-12-08
FIXION INTERLOCKING NAIL (FIXION IL NAIL) (K002783)Disco-O-Tech Medical Technologies, Ltd.2000-12-05
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM (K002775)Hand Innovations, Inc.2000-12-05
ACETABULAR PLATES (K002941)Encore Orthopedics, Inc.2000-12-04
U1 HIP SYSTEM (K994078)United Orthopedic Corp.2000-12-04
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (K002755)T. Korossurgical Instruments Corp.2000-12-04
DEPUY C-STEM SYSTEM (K003421)DePuy Orthopaedics, Inc.2000-12-01
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS (K002740)Smith & Nephew, Inc.2000-11-30
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL (K003429)Biomet, Inc.2000-11-30
V-40/C-TAPER ADAPTER SLEEVE (K003379)Howmedica Osteonics Corp.2000-11-30
OSTEONICS ALUMINA C-TAPER HEAD (K003391)Howmedica Osteonics Corp.2000-11-28
COD COMPRESSION OSTEOTOMY DEVICE (K002184)Walter Abendschein, M.D.2000-11-24
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR (K002764)Hydrocision, Inc.2000-11-24
ISS OFFSET HEADS (K003428)Biomet, Inc.2000-11-24
ONCOLOGY SALVAGE SYSTEM (K002757)Biomet, Inc.2000-11-24
METRX SYSTEM (K002931)Medtronic Sofamor Danek, Inc.2000-11-24
VERSALINK TITANIUM ROD-TO-ROD COUPLERS (K003384)Osteotech, Inc.2000-11-24
ALUMINA V40 HEAD (K003413)Howmedica Osteonics Corp.2000-11-24
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM (K002683)Wrightmedicaltechnologyinc2000-11-22
RADIAL HEAD IMPLANT (K002644)Avanta Orthopaedics, Inc.2000-11-20
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW (K002605)Synthes (Usa)2000-11-20
LITWIN CRUICATE ANCHOR (K002600)Instrument Makar, Inc.2000-11-15
INTER-OP DURASUL ACETABULAR INSERTS (4MM) (K002575)Sulzer Orthopedics, Inc.2000-11-15
AMT SPINAL SYSTEM (K002059)Micron Precision Engineering, Inc.2000-11-13
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K002552)Howmedica Osteonics Corp.2000-11-13
PRECIMED TRAUMA SYSTEM (K002486)Patrick Berdoz2000-11-09
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ (K003181)Implex Corp.2000-11-07
BIOMET SCK KNEE SYSTEM (K003296)Biomet, Inc.2000-11-06
PE.R.I. II KNEE FRACTURE SYSTEM (K003235)DePuy Orthopaedics, Inc.2000-11-06
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM (K001044)Acme Spine, LLC2000-11-03
BIOMET LATERAL TROCH PLATE (K003294)Biomet, Inc.2000-11-03
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT (K003131)Biomet, Inc.2000-11-02
SIMPLICITY SPINAL SYSTEM (K002103)Medtronic Sofamor Danek USA, Inc.2000-11-02
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) (K002362)Synthes (Usa)2000-11-01
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM (K002361)Synthes (Usa)2000-10-31
SYNTHES USS (10.0MM SIDE OPENING SCREWS) (K003061)Synthes2000-10-30
WUJIN #3 TIBIAL NAIL (K002325)Biologically Oriented Prostheses2000-10-30
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS (K002356)Sulzer Orthopedics, Inc.2000-10-30
MITEK CUFFTACK (K003076)Mitek Products2000-10-27
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA (K002335)Sulzer Orthopedics, Inc.2000-10-25
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (K001741)Radionics, Inc.2000-10-23
BROOKER FEMORAL NAILS (K002278)Biomet Orthopedics, Inc.2000-10-23
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM (K002980)Ebi, L.P.2000-10-23
GLOBAL SPINAL FIXATION SYSTEM (K001668)D.K.M. Co., Ltd.2000-10-19
SMALL STATURE USS (K994121)Synthes (Usa)2000-10-17
MODIFICATION TO ISOBAR SPINAL SYSTEM (K002959)Encore Orthopedics, Inc.2000-10-16
TC-PLUS SOLUTION KNEE (K000666)Plus Orthopedics2000-10-13
XIA SPINE SYSTEM (K002858)Howmedica Osteonics Corp.2000-10-13
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K002883)DePuy Orthopaedics, Inc.2000-10-13
PINS AND WIRES (K002125)Implant Resource, Inc.2000-10-11
SPEEDLINK TRANSVERSE CONNECTOR (K002082)Spinal Concepts, Inc.2000-10-06
SPL CRIMP SYSTEM (K002110)Pioneer Surgical Technology2000-10-06
SYNTHES PROXIMAL HUMERAL NAIL (K002729)Synthes (Usa)2000-10-06
BIOMET BI-POLAR SHOULDER SYSTEM (K002998)Biomet, Inc.2000-10-06
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM (K002592)Interpore Cross Intl.2000-10-06
ASCEND SPINAL FIXATION SYSTEM (K002069)Spinal Innovations, LLC2000-10-05
XIA SPINE SYSTEM (K002505)Howmedica Osteonics Corp.2000-10-05
BROOKER TIBIA NAILS (K002057)Biomet Orthopedics, Inc.2000-10-04
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (K002484)Electro Medical Systems SA2000-10-04
ASCENT XXL CLOSED BOX FEMORAL COMPONENT (K002772)Biomet, Inc.2000-10-04
ENDIUS ENDOSCOPIC ACCESS SYSTEM (K002437)Endius, Inc.2000-10-02
TORNIER TOTAL ELBOW PROSTHESIS (K000003)Tornier2000-10-02
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) (K002710)Synthes (Usa)2000-09-29
MODIFICATION TO PROVIDENT HIP SYSTEM (K002796)Stelkast Company2000-09-28
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K002399)Medtronic Sofamor Danek, Inc.2000-09-27
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (K001984)Stelkast Company2000-09-27
SYNTHES MODULAR FOOT SYSTEM (K001941)Synthes (Usa)2000-09-22
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES (K001945)Synthes (Usa)2000-09-22
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