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Orthopedic

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

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RecordFirmDate
CONMED LINVATEC INTERCEPT IMPLANT (K092998)Linvatec Corp.2009-12-23
PATHWAY IVB/VBR (K092904)Custom Spine, Inc.2009-12-22
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM (K091926)Choicespine, LP2009-12-22
VERTECEM (K090435)Teknimed, S.A.2009-12-21
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS (K091543)Smith & Nephew, Inc.2009-12-21
RESTORATION ADM SYSTEM X3 ACETABULAR (K093644)Howmedica Osteonics Corp.2009-12-18
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR (K093428)Smith & Nephew Endoscopy, Inc.2009-12-17
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS (K093646)DePuy Orthopaedics, Inc.2009-12-17
MODIFICATION TO CASPIAN SPINAL SYSTEM (K093534)K2m, Inc.2009-12-16
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513)Conformis, Inc.2009-12-16
FOOT AND HAND MOTION SYSTEM (K091118)Newclip Technics2009-12-16
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM (K093549)Biomet Manufacturing Corp2009-12-16
MODIFICATION TO:CD HORIZON SPINAL SYSTEM (K092325)Medtronic Sofamor Danek USA, Inc.2009-12-15
LIFE SPINE STAND-ALONE SPACER SYSTEM (K091301)Life Spine2009-12-15
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR (K093228)Smith & Nephew, Inc.2009-12-15
INTEGRA TOTAL WRIST FUSION SYSTEM (K093163)Integra LifeSciences Corporation2009-12-15
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056)Smith & Nephew, Inc.2009-12-15
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (K092548)Extremity Medical, LLC2009-12-15
AFGHAN EXTERNAL FIXATOR (K092002)Smith & Nephew, Inc.2009-12-10
MODIFICATION TO LANX SPINAL FIXATION SYSTEM (K093285)Lanx, LLC2009-12-10
EIDOSMED, MODEL EDG4.0 (K091992)Eidosmed, LLC2009-12-09
WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES (K092914)Medshape Solutions2009-12-09
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS (K090686)Sic Brevetti S.R.L.2009-12-08
INTEGRA MOZAIK AND OS MOLDABLE MORSELS (K091302)Integra LifeSciences Corporation2009-12-04
XIA 4.5 SPINAL SYSTEM (K092605)Stryker Spine2009-12-03
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM (K093434)Medtronic Sofamor Danek2009-12-02
DYNA LOCKING IM NAIL (K092771)U&I Corp.2009-12-02
DUOWEDGE SYNTHETIC BONE SUBSTITUTE (K073214)Kasios2009-12-01
PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) (K092017)Captiva Spine, Inc.2009-12-01
BIOMET VISION FOOTRING SYSTEM (K093057)Ebi, L.P.2009-12-01
EXPEDIUM SPINE SYSTEM (K092473)Depuy Spine, Inc.2009-11-25
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (K092773)Tecres S.P.A.2009-11-24
ZIMMER MMC CUP (K091003)Zimmer GmbH2009-11-24
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K092656)Lanx, Inc.2009-11-24
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS (K092178)Howmedica Osteonics Corp.2009-11-20
BIODRIVE MICRO SCREW SYSTEM (K092670)Ebi,Llc D/B/A Biomet Trauma2009-11-19
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) (K091263)Materialise NV2009-11-19
KRD1 PEDICLE SCREW SYSTEM (K092420)Spinefrontier, Inc.2009-11-19
PIONEER SURGICAL NANOSS BVF-E (K091031)Pioneer Surgical Technology2009-11-17
METASUL TAPER LINERS, METASUL FEMORAL HEADS (K091973)Zimmer GmbH2009-11-17
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS (K092556)Synthes (Usa)2009-11-17
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) (K092609)Synthes (Usa)2009-11-17
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (K092659)Spinal USA2009-11-17
INTREPID SPINAL SYSTEM (K091813)Medtronic Sofamor Danek2009-11-17
INDISCAL ASPIRATION DEVICE AND ACCESSORIES (K092877)Baylis Medical Co., Inc.2009-11-17
XTEND ANTERIOR CERVICAL PLATE SYSTEM (K092146)Globus Medical, Inc.2009-11-16
MAGNUM NAIL (K093089)Robert Reid, Inc.2009-11-13
LEFORTE NEUROSYSTEM BONE SCREW (K091686)Jeil Medical Corporation2009-11-13
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) (K091725)U&I Corp.2009-11-09
CLAMPFIX (K090605)Synthes (Usa)2009-11-06
CASPIAN SPINAL SYSTEM (K092640)K2m, Inc.2009-11-06
ASCENSION CANNULATED SCREW SYSTEM (K092440)Ascension Orthopedics, Inc.2009-11-05
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX (K091309)Dgimed Ortho, Inc.2009-11-05
PECTUS STRUT (K082399)Koros USA, Inc.2009-11-05
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N (K092133)Arthrocare Corp.2009-11-05
ABG II MODULAR HIP STEM (K092406)Howmedica Osteonics Corp.2009-11-04
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093170)Spineart2009-11-04
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (K092386)Smith & Nephew, Inc.2009-11-03
SEC VBR (K091743)Innvotec Surgical, Inc.2009-11-02
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM (K092317)Deroyal Industries, Inc.2009-11-02
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (K091607)Etex Corp.2009-11-02
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER (K091531)Choice Spine, Llp2009-11-02
SPINAL FIXATION SYSTEM (K092536)Lanx, Inc.2009-10-30
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES (K090887)SpineCraft2009-10-30
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS (K091566)Zimmer GmbH2009-10-28
NORM SPINAL SYSTEM (K092011)Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar2009-10-28
ANKLE ARTHRODESIS PLATE SYSTEM (K090139)Tornier, Inc.2009-10-27
REVERSE SHOULDER PROSTHESIS (K092873)Djo Surgical2009-10-27
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION (K092381)Ibalance Medical, Inc.2009-10-27
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT (K092150)Biomet, Inc.2009-10-27
GRS GLENOID RESURFACING SYSTEM (K091196)Arthrosurface, Inc.2009-10-27
TSRH SPINAL SYSTEM (K093058)Medtronic Sofamor Danek, Inc.2009-10-26
ULC SPINAL PEDICLE SCREW SYSTEM (K083077)Otis Biotech Co., Ltd.2009-10-26
CURIOS (K090641)Progentix Orthobiology BV2009-10-23
INTERFACE ACETABULAR CUP LINERS (K092443)Omni Life Science, Inc.2009-10-23
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT (K090897)Howmedica Osteonics Corp.2009-10-23
VERTAPLEX HV (SINGLE PACK AND DUAL PACK) (K091606)Stryker Corp.2009-10-23
COMET ANTERIOR CERVICAL PLATE SYSTEM (K090751)Apollo Spine, Inc.2009-10-23
REJUVENATE MODULAR STEM (K092561)Howmedica Osteonics Corp.2009-10-20
DISTRACTABLE WAVE CAGE (K083626)Advanced Medical Technology, Inc.2009-10-19
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES (K092898)Conmed Linvatec2009-10-19
C-THRU SPINAL SYSTEM (K092336)Ebi, L.P.2009-10-15
MAXMORESPINE TOM STICK (K083552)Hoogland Spine Products, GmbH2009-10-09
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT (K090705)Ortho Development Corp.2009-10-09
LAMINOPLASTY FIXATION SYSTEM (K091623)Nuvasive, Inc.2009-10-09
HOFFMAN XPRESS LINE EXTENSION (K092834)Howmedica Osteonics Corp.2009-10-08
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM (K092287)Nuvasive, Inc.2009-10-06
INTERPLATE C (K092070)Rsb Spine, LLC2009-10-06
ADDPLUS (K090841)Ulrich GmbH & Co. KG2009-10-05
SYNERGY CANNULATED SCREW SYSTEM (K092082)Synergy Surgical Technologies, LLC2009-10-02
TSRH SPINAL SYSTEM (K092676)Medtronic Sofamor Danek, Inc.2009-10-02
DYNESYS TOP-LOADING SPINAL SYSTEM (K092234)Zimmer Spine, Inc.2009-10-01
PARCUS PPEK CF INTERFERENCE SCREW (K091093)Parcus Medical, LLC2009-09-30
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 (K091094)Parcus Medical, LLC2009-09-30
PERIMETER INTERBODY FUSION DEVICE (K090353)Medtronic Sofamor Danek2009-09-29
JOURNEY BCS KNEE SYSTEM (K091014)Smith & Nephew, Inc.2009-09-29
KAINOS+ (K090387)Signus Medizintechnik GmbH2009-09-28
DBX DEMINERALIZED BONE MATRIX PUTTY (K091218)Musculoskeletal Transplant Foundation2009-09-28
SYNTHES LOCKING HAND PLATES (K092247)Synthes (Usa)2009-09-25
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT (K091280)Maxx Orthopedics, Inc.2009-09-25
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