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Orthopedic

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

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RecordFirmDate
GROWTH CONTROL PLATING SYSTEM (K070823)Biomet Trauma2007-05-07
LAGWIRE SYSTEM (K070393)Fxdevices2007-05-04
ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K070527)Medtronic Sofamor Danek2007-05-04
REUNION HA FRACTURE STEM (K070963)Howmedica Osteonics Corp.2007-05-04
NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM (K070681)Alphatec Spine, Inc.2007-05-04
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM (K070368)Stryker Corp.2007-05-04
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES (K070399)Biomet Manufacturing, Inc.2007-05-04
100KGY E-POLY MAXROM ACETABULAR LINERS (K070364)Biomet, Inc.2007-05-03
RANGE SPINAL SYSTEM (K070229)K2m, Inc.2007-05-03
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM (K070843)Synthes (Usa)2007-05-02
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR (K070925)Depuy Mitek, A Johnson & Johnson Company2007-05-02
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS (K070906)Zimmer, Inc.2007-05-01
AESCULAP RESORBABLE PIN, MODEL FR735 (K070178)Aesculap Implant System, Inc.2007-04-30
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (K070292)Zimmer GmbH2007-04-26
THEKEN VU MESH VBR SYSTEM (K070381)Theken Spine, LLC2007-04-25
4S SPINAL SYSTEM (K063708)Taeyeon Medical Co., Ltd.2007-04-24
XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY (K070082)Vertebration,Inc2007-04-20
MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM (K070775)Globus Medical, Inc.2007-04-19
INTERPLATE VBR SYSTEM (K070316)Rsb Spine, LLC2007-04-19
PRO OSTEON 500R (K063346)Ebi, L.P.2007-04-18
SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX (K070181)Sintea Biotech, Inc.2007-04-18
INQU (K063359)Isto Technologies, Inc.2007-04-16
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE (K070227)Arthrocare Corp.2007-04-16
SIMPLEX CERVICAL FIXATION SYSTEM (K070335)Pisharodi Surgicals, Inc.2007-04-16
POLARCUP DUAL MOBILITY SYSTEM (K070278)Plus Orthopedics AG2007-04-16
MODIFICATION TO STAXX FX SYSTEM (K063606)Spine Wave, Inc.2007-04-13
OMEGA 3 SUPRACONDYLAR PLATE (K070454)Howmedica Osteonics Corp.2007-04-12
OSTEOFIX BONE VOID FILLER (K070220)Calcitec, Inc.2007-04-12
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K070367)Endius, Inc.2007-04-12
ENDOBUTTON DIRECT (K070167)Smith & Nephew Inc., Endoscopy Division2007-04-12
BIODUCT (K053492)Bioduct, LLC2007-04-12
EXPEDIUM SFX CROSS CONNECTOR SYSTEM (K070300)Depuy Spine, Inc.2007-04-10
VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) (K070218)Vertiflex (Tm), Incorporated2007-04-06
CAPSURE PEDICLE SCREW SYSTEM (K070245)Spine Wave, Inc.2007-04-05
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 (K070221)Encore Medical L.P.2007-04-04
SYNFIX -LR (K062083)Synthes Spine Co.Lp2007-04-03
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM (K070273)Nuvasive, Inc.2007-04-03
CORIN UNIPOLAR MODULAR HEAD (K063791)Corin USA2007-04-03
ECHO BI-METRIC PRESS-FIT STEMS (K070274)Biomet Manufacturing Corp2007-04-03
BLUE SHARK (K070016)Meridan Medical2007-04-02
CONMED LINVATEC SMART GUARD IRRIGATOR (K070233)Conmed Linvatec2007-04-02
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K070551)Pioneer Surgical Technology2007-03-29
NEWDEAL COMPRESSION PLATE (K070447)Newdeal Sas2007-03-29
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW (K070507)Science For Biomaterials2007-03-29
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER (K070525)Wrightmedicaltechnologyinc2007-03-29
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES (K070208)Synthes (Usa)2007-03-28
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION (K070052)Vilex, Inc.2007-03-28
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE (K070169)KLS Martin L.P.2007-03-26
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM (K063430)Stryker Spine2007-03-22
ADVANCE SPIKED POROUS TIBIAL BASE (K063128)Wrightmedicaltechnologyinc2007-03-21
MEMOMETAL FIXOS SCREWS (K070039)Memometal Technologies2007-03-21
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 (K070033)Memometal Technologies2007-03-19
MEMOMETAL MEMORY STAPLES (K070031)Memometal Technologies2007-03-19
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K070214)Zimmer, Inc.2007-03-16
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) (K063432)Conformis, Inc.2007-03-16
EXACTECH NOVATION CROWN CUP AND LINERS (K070479)Exactech, Inc.2007-03-15
UNITY ALPHA SYSTEM (K062820)Bonutti Research, Inc.2007-03-15
STRYKER FOOT PLATING SYSTEM (K063875)Howmedica Osteonics Corp.2007-03-15
MODIFICATION TO S4 SPINAL SYSTEM (K062327)Aesculap, Inc.2007-03-14
VERTE-STACK SPINAL SYSTEM (K070173)Medtronic Sofamor Danek, Inc.2007-03-14
LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM (K070285)Life Spine2007-03-13
ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K063248)Medtronic Sofamor Danek2007-03-13
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM (K062872)Synthes (Usa)2007-03-13
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS (K062994)Biomet Manufacturing Corp2007-03-09
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K063464)Atlas Spine, Inc.2007-03-09
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS (K070369)Biomet, Inc.2007-03-09
SERIES II CONSTRAINED ACETABULAR LINERS (K063552)Howmedica Osteonics Corp.2007-03-08
SYSTEM 12 CONSTRAINED ACETABULAR LINERS (K063550)Howmedica Osteonics Corp.2007-03-08
PCA CONSTRAINED ACETABULAR LINERS (K063445)Howmedica Osteonics Corp.2007-03-08
SYNTHES (USA) ELBOW HINGE FIXATOR (K063832)Synthes (Usa)2007-03-07
DEPUY ASR TAPER SLEEVE ADAPTER (K070359)DePuy Orthopaedics, Inc.2007-03-06
PLC SUTURE ANCHOR (K063726)Smith & Nephew Inc., Endoscopy Div.2007-03-06
ARTHREX CROSSPIN, MODEL AR-1964P (K063719)Arthrex, Inc.2007-03-06
T2 SCEPTOR SPINAL SYSTEM (K063491)Medtronic Sofamor Danek2007-03-05
DBX DEMINERALIZED BONE MATRIX MIX (K063676)Musculoskeletal Transplant Foundation2007-03-05
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM (K063298)Osteomed LP2007-03-02
PROMOS MODULAR SHOULDER SYSTEM (K063578)Plus Orthopedics AG2007-03-02
ADVANCE STATURE FEMORAL COMPONENT (K063731)Wrightmedicaltechnologyinc2007-03-02
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES (K063633)DePuy Orthopaedics, Inc.2007-03-02
MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 (K063588)Conmed Linvatec Biomaterials2007-03-02
DALL-MILES SYSTEM (K070170)Stryker Orthopaedics2007-03-02
S4 SPINAL SYSTEM (K062085)Aesculap2007-03-02
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES (K070294)Synthes (Usa)2007-03-01
BIOMET TIBIAL LOCKING NAIL SYSTEM (K063570)Biomet Manufacturing Corp2007-02-27
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K063205)Atlas Spine, LLC2007-02-26
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT (K063857)Howmedica Osteonics Corp.2007-02-26
ORIGEN DBM WITH BIOACTIVE GLASS (K062459)Nanotherapeutics2007-02-26
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE (K063100)Medtronic Sofamor Danek, Inc.2007-02-23
EQUINOXE REVERSE SHOULDER SYSTEM (K063569)Exactech, Inc.2007-02-23
ALEUTIAN SPACER SYSTEM (K063399)K2m, Inc.2007-02-23
SBI LATERAL RADIO CAPITELLUM (K070236)Small Bone Innovations, Inc.2007-02-21
ALTRA FX HIP SYSTEM (K063614)Biomet Manufacturing Corp2007-02-20
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM (K063544)K2m, Inc.2007-02-14
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS (K062200)Collagen Matrix, Inc.2007-02-13
CINCH BONE ANCHOR SYSTEM (K062739)Sapphire Medical, Inc.2007-02-13
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K062012)Aesculap, Inc.2007-02-09
LISFRANC PLATE (K063820)New Deal, S.A.2007-02-08
MODIFICATION TO TTC PLATES (K070160)New Deal, S.A.2007-02-08
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY (K061131)Orthocon, Inc.2007-02-08
MODIFICATION TO LAPIDUS PLATE (K070241)New Deal, S.A.2007-02-08
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