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Orthopedic

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

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RecordFirmDate
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) (K031401)Disco-O-Tech Medical Technologies, Ltd.2003-08-06
BONESOURCE BVF (K031435)Howmedica Osteonics2003-08-04
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT (K031480)Howmedica Osteonics Corp.2003-07-31
PEEK TETRIS SPINAL IMPLANT (K031757)Signus Medical, LLC2003-07-30
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS (K031381)Seaspine2003-07-30
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES (K032058)Alliance Medical Corp.2003-07-30
VERTE-STACK SPINAL SYSTEM (K031780)Medtronic Sofamor Danek2003-07-30
UC-PLUS SOLUTION UNICONDYLAR KNEE (K032052)Plus Orthopedics2003-07-25
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 (K031981)Linvatec Biomaterials, Ltd.2003-07-25
OXINIUM FEMORAL HEADS (K030766)Smith & Nephew, Inc.2003-07-25
STRYKER PLATING SYSTEM PERIARTICULAR PLATES (K031959)Howmedica Osteonics Corp.2003-07-25
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM (K032059)Aesculap, Inc.2003-07-25
THERIFIL BONE FILLER (K031040)Therics, Inc.2003-07-24
HOFFMANN II COMPACT BALTIMORE COUPLING (K031941)Howmedica Osteonics Corp.2003-07-24
EBI SPINELINK SPINAL FIXATION SYSTEM (K031424)Ebi, L.P.2003-07-22
EBI SPINELINK - II SPINAL FIXATION SYSTEM (K031355)Ebi, L.P.2003-07-22
POLYGRAFT BONE GRAFT SUBSTITUTE (K030288)Osteobiologics, Inc.2003-07-17
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM (K030087)Spinal Concepts, Inc.2003-07-17
ACUMED SMALL BONE LOCKING ROD SYSTEM II (K031438)Acumed, LLC2003-07-17
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM (K031893)Howmedica Osteonics Corp.2003-07-17
OSTEO-G BONE VOID FILLER SYSTEM (K031319)Aspine USA, Inc.2003-07-17
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE (K031817)Wrightmedicaltechnologyinc2003-07-17
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM (K031201)Ortho Development Corp.2003-07-15
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (K031203)DePuy Orthopaedics, Inc.2003-07-14
EXTERNAL FIXATION SYSTEMS (K031181)Smith & Nephew, Inc.2003-07-14
SYNTHES SMALL COBINATION CLAMP-MR SAFE (K031724)Synthes (Usa)2003-07-14
PCW PERCUTANEOUS COMPRESSION WIRE (K031050)Millennium Medical Technologies, Inc.2003-07-14
TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE (K031183)Centerpulse Orthopedics, Inc.2003-07-14
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE (K031914)Spinal Concepts, Inc.2003-07-12
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 (K031823)Implex Corp.2003-07-11
EBI XFIX OPTIROM KNEE FIXATOR (K031093)Ebi, L.P.2003-07-10
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM (K031276)Synthes (Usa)2003-07-02
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS (K031734)Biomet, Inc.2003-07-01
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 (K031685)Smith & Nephew, Inc.2003-07-01
DEPUY CERAMIC FEMORAL HEADS (K031803)DePuy Orthopaedics, Inc.2003-07-01
EBI P148 SPINAL FIXATION SYSTEM (K031423)Ebi, L.P.2003-06-27
U&I, OPTIMA, SPINAL SYSTEM (K031585)U&I Corp., America2003-06-27
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031888)Medtronic Sofamor Danek2003-06-27
BLACKSTONE SURGICAL TITANIUM MESH (K030744)Blackstone Medical, Inc.2003-06-27
SMISSON STABILIZATION SYSTEM (K021979)Smisson-Cartledge2003-06-27
SUSTAIN SPACER (K031302)Globus Medical, Inc.2003-06-27
CD HORIZON SPINAL SYSTEM (K031655)Medtronic Sofamor Danek USA, Inc.2003-06-27
ORIA CLARIS (K023378)Ortho Tec, LLC2003-06-27
RAPIDFIRE SELF DRILLING SCREWS (K031751)Walter Lorenz Surgical, Inc.2003-06-26
MINILOK QUICKANCHOR PLUS (K030995)Mitek Worldwide2003-06-26
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) (K030581)Blackstone Medical, Inc.2003-06-26
EBI XFIX DFS SYSTEM (K031645)Ebi, L.P.2003-06-25
U & I AMERICA SPINAL HOOK SYSTEM (K031595)U&I Corp., America2003-06-24
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 (K031572)Zimmer, Inc.2003-06-24
MODIFICATION TO COLORADO 2 SPINAL SYSTEM (K030875)Medtronic Sofamor Danek, Inc.2003-06-24
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X (K031154)Sintea Biotech, Inc.2003-06-24
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM (K031725)Synthes (Usa)2003-06-24
DEPUY ACROMED VBR SYSTEM (K031635)Depuyacromed2003-06-23
INION OTPS BIODEGRADABLE FIXATON SYSTEM (K030900)Inion , Ltd.2003-06-19
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 (K031452)Ortho Tec, LLC2003-06-18
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY (K031605)Smith & Nephew, Inc.2003-06-18
VANTAGE ANTERIOR FIXATION SYSTEM (K031533)Medtronic Sofamor Danek, Inc.2003-06-13
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 (K031083)Opus Medical, Inc.2003-06-12
HA PMI FLANGED ACETABULAR COMPONENT (K030861)Biomet, Inc.2003-06-12
BLACKSTONE POSTERIOR CERVICAL SYSTEM (K030197)Blackstone Medical, Inc.2003-06-12
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS (K031495)DePuy Orthopaedics, Inc.2003-06-11
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS (K030519)Hand Biomechanics Lab, Inc.2003-06-10
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM (K031609)Swiss Orthopedic Solutions, Inc.2003-06-09
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE (K031573)Synthes (Usa)2003-06-06
CUFFLOK ANCHOR (K031519)Mitek Worldwide2003-06-06
PLUS ORTHOPEDICS CEMENTED HIP STEM (K031165)Plus Orthopedics2003-06-06
MSD CABLE REDUCTION SYSTEM (K030816)Medtronic Sofamor Danek2003-06-06
BIO-MODULAR SHOULDER SYSTEM (K030710)Biomet, Inc.2003-06-04
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM (K030724)Zimmer, Inc.2003-06-03
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (K030848)Karl Storz Endoscopy2003-06-02
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) (K030972)Disc-O-Tech Medical Technologies, Ltd.2003-05-30
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM (K023887)Inion , Ltd.2003-05-30
EXOJET TISSUE MANAGEMENT SYSTEM (K031406)Mitek Worldwide2003-05-30
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM (K031508)Synthes (Usa)2003-05-30
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) (K031219)Orthofix, Inc.2003-05-28
ENCORE ANTERIOR SPINAL STAPLE SYSTEM (K030667)Encore Medical L.P.2003-05-28
GENESIS II TOTAL KNEE SYSTEM (K030612)Smith & Nephew, Inc.2003-05-27
GMRS PRESS FIT STEMS WITH PUREFIX HA (K031217)Howmedica Osteonics2003-05-23
APEX MODULAR ACETABULAR CUP (K031110)Apex Surgical, LLC2003-05-22
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM (K030623)Smith & Nephew, Inc.2003-05-22
HLS UNI EVOLUTION PROSTHESIS (K022211)Tornier2003-05-22
TEXAS T - PLATE (K031334)Biomet, Inc.2003-05-22
CEMEX SYSTEM FAST (K031430)Exactech, Inc.2003-05-22
OSSATURA BCP BONE VOID FILLER (K030131)Isotis NV2003-05-20
CALLOS (K030554)Skeletal Kinetics, LLC2003-05-20
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218)Tornier2003-05-16
CD HORIZON SPINAL SYSTEM (K030932)Medtronic Sofamor Danek, Inc.2003-05-16
MODIFICATION TO HORIZON SPINAL SYSTEM (K030840)Medtronic Sofamor Danek, Inc.2003-05-15
MODIFICATION TO EASYS TRANSVERSE CONNECTION (K031290)Scient'X USA, Inc.2003-05-13
SURGICAL SIMPLEX P WITH TOBRAMYCIN (K014199)Howmedica Osteonics Corp.2003-05-06
ADHOC CLAW (K023963)Future Medical Systems, Inc.2003-05-05
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES (K031178)Synthes (Usa)2003-05-05
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES (K030733)Zimmer, Inc.2003-05-01
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM (K031162)Smith & Nephew, Inc.2003-05-01
ORTHOPEDIC WIRE (K031127)Howmedica Osteonics Corp.2003-04-28
MODIFICATION TO MODULAR PLUS REVISION STEM (K030971)Plus Orthopedics2003-04-24
AMATOMICAL SHOULDER WITH REMOVABLE HEAD (K030259)Centerplus Orthopedics, Inc.2003-04-24
MODIFICATION TO XIA STAINLESS STEEL SYSTEM (K031090)Howmedica Osteonics Corp.2003-04-24
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS (K030979)DePuy Orthopaedics, Inc.2003-04-24
IMPACT SUTURE ANCHOR. MODEL 433510 (K030388)Bionx Implants, Ltd.2003-04-24
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