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Orthopedic

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

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RecordFirmDate
NEXFLEX TOTAL HIP SYSTEM (K042252)Alphatec/Nexmed2004-12-06
MODULAR ARTHRODESIS NAIL (K042409)Biomet, Inc.2004-12-02
MX POLYAXIAL PEDICLE SCREW (K043001)Scient'X2004-12-01
TRIGEN HINDFOOT FUSION NAIL (K043052)Smith & Nephew, Inc.2004-11-24
KASIOS TCP (K042340)Kasios Biomaterials2004-11-24
KOBRA GPS FIXATION SYSTEM (K042859)Medtronic Vertelink, Inc.2004-11-24
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM (K043082)Signus Medizintechnik GmbH2004-11-23
SILHOUETTE SPINAL FIXATION SYSTEM (K042702)Zimmer Spine, Inc.2004-11-23
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT (K042883)Howmedica Osteonics Corp.2004-11-23
UNI-THREAD SPINAL SYSTEM (K042640)Spine Vision, Inc.2004-11-23
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K042544)Depuy Spine, Inc.2004-11-23
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX (K043061)Zimmer Trabecular2004-11-23
MODIFICATION TO PROTEX STABILIZATION SYSTEM (K042953)Globus Medical, Inc.2004-11-22
PERFECTA FEMORAL STEM (K031402)Wrightmedicaltechnologyinc2004-11-22
MX MONOAXIAL PEDICLE SCREW (K042964)Scient'X2004-11-22
VENTURE ANTERIOR CERVICAL PLATING SYSTEM (K042922)Medtronic Sofamor Danek, Inc.2004-11-19
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H (K042966)Linvatec Biomaterials, Ltd.2004-11-19
SMITH & NEPHEW MODULAR HIP (K042127)Smith & Nephew, Inc.2004-11-19
CD HORIZON SPINAL SYSTEM (K042886)Medtronic Sofamor Danek2004-11-18
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES (K042761)Zimmer, Inc.2004-11-17
ALUMINA HEAD (K042035)Fournitures Hospitalieres Industrie2004-11-17
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (K041443)Osteoimplant Technology, Inc.2004-11-16
DYNAMOMETER - MODEL FCE AND MODEL MSC (K042889)Ametek2004-11-16
ORTHOFIX VOLAR DISTAL RADIAL PLATE (K042766)Orthofix, Inc.2004-11-16
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES (K042895)Synthes (Usa)2004-11-16
ASCENSION PYROSPHERE (PCS) (K042690)Ascension Orthopedics, Inc.2004-11-13
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE (K042914)Opus Medical, Inc.2004-11-12
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 (K041595)Biopro, Inc.2004-11-12
FASTIN RC ANCHOR (K041075)Depuy Mitek, A Johnson & Johnson Company2004-11-09
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS (K041170)Howmedica Osteonics Corp.2004-11-09
SPIRALOK ANCHOR (K041069)Depuy Mitek, A Johnson & Johnson Company2004-11-09
NOVATION 12/14 PRESS-FIT FEMORAL STEM (K042842)Exactech, Inc.2004-11-09
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS (K042029)Biomet, Inc.2004-11-09
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE (K042796)Coapt Systems, Inc.2004-11-05
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM (K042798)Interpore Cross Intl.2004-11-04
MSD SILO SPINAL SYSTEM (K042210)Medtronic Sofamor Danek2004-11-04
METAL/METAL HIP SYSTEM (K040354)Encore Medical L.P.2004-11-04
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING (K042337)Zimmer, Inc.2004-11-04
ARTHREX TRIMIT FAMILY (K041189)Arthrex, Inc.2004-11-04
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX (K042776)Zimmer, Inc.2004-11-04
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE (K042778)Linvatec Corp.2004-11-04
ARTHREX TENODESIS SCREW FAMILY (K041356)Arthrex, Inc.2004-11-04
CD HORIZON SPINAL SYSTEM (K042790)Medtronic Sofamor Danek2004-11-04
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS (K042093)Biomet, Inc.2004-11-01
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K041100)Zimmer, Inc.2004-10-29
NCB PLATING SYSTEM (K042695)Zimmer GmbH2004-10-29
TI - SCREW ANCHOR SP (K042460)Arthrotek, Inc.2004-10-29
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES (K042598)Zimmer, Inc.2004-10-29
SYNTHES (USA) LCP WRIST FUSION PLATES (K042355)Synthes (Usa)2004-10-27
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K042673)Alphatec/Nexmed2004-10-27
EBI CAS SPINE SPACER SYSTEM (K042268)Ebi, L.P.2004-10-27
EXACTECH EQUINOXE SHOULDER SYSTEM (K042021)Exactech, Inc.2004-10-26
SMARTMIX PRE-FILLED MIXING SYSTEM (K042591)DePuy Orthopaedics, Inc.2004-10-22
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 (K042305)Ossacur AG2004-10-21
ARTHROTEK MENISCAL HYBRID DEVICE (K041988)Biomet, Inc.2004-10-20
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM (K041961)Scandius Biomedical, Inc.2004-10-20
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED (K033943)Centerpulse Orthopedics, Inc.2004-10-18
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES (K042271)Zimmer, Inc.2004-10-13
T2 PROXIMAL HUMERAL NAIL (K042396)Howmedica Osteonics Corp.2004-10-08
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM (K041353)Jri Manufacturing, Ltd.2004-10-08
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042524)Medtronic Sofamor Danek2004-10-08
DORSAL INTRAMEDULLARY PLATE (K042437)Deo Volente Orthopaedics, LLC2004-10-08
ORION ANTERIOR CERVICAL PLATING SYSTEM (K042499)Medtronic Sofamor Danek2004-10-07
IIIZAROV PULLEY SYSTEM (K042436)Smith & Nephew, Inc.2004-10-07
MODIFICATION TO EQUATION FIXATION SYSTEM (K042453)Medtronic Sofamor Danek, Inc.2004-10-07
VERTEX RECONSTRUCTION SYSTEM (K042498)Medtronic Sofamor Danek2004-10-07
EXCELLA-M SPINAL SYSTEM (K042143)Innovasis, Inc.2004-10-07
LOCON VLS DISTAL RADIUS PLATE SYSTEM (K042358)Wrightmedicaltechnologyinc2004-10-07
TITANIUM TELEGRAPH HUMERAL NAIL (K042332)Fournitures Hospitalieres Industrie2004-10-07
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) (K042135)Synthes (Usa)2004-10-07
SYNTHES LOW PROFILE RECONSTRUCTION PLATES (K042377)Synthes (Usa)2004-10-07
NOVEL VBR SPINAL SYSTEM (K042201)Alphatec/Nexmed2004-10-07
MAESTRO TOTAL WRIST (K042032)Biomet, Inc.2004-10-07
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS (K042356)Synthes (Usa)2004-10-07
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM (K042458)A.M. Surgical, Inc.2004-10-07
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM (K042508)Depuy Spine, Inc.2004-10-07
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM (K042440)Alphatec/Nexmed2004-10-07
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM (K042514)Blackstone Medical, Inc.2004-10-07
ACUMED ANATOMIC RADIAL HEAD SYSTEM (K041858)Acumed, LLC2004-10-05
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K041698)Axya Medical, Inc.2004-10-05
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS (K040601)Exactech, Inc.2004-10-04
SYNTHES CONTOURED SYNMESH SPACER (K041389)Synthes Spine2004-10-01
EXACTECH OPTETRAK UNICONDYLAR KNEE (K040889)Exactech, Inc.2004-10-01
M2A MAGNUM SYSTEM (K042037)Biomet, Inc.2004-10-01
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042402)Medtronic Sofamor Danek, Inc.2004-10-01
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K041808)Endius, Inc.2004-10-01
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ (K040630)Implex Corp.2004-09-30
SHOULDER FIXATION SYSTEM (K042059)Hand Innovations, Inc.2004-09-30
ENDOTINE MIDFACE B 4.5 DEVICE (K041835)Coapt Systems, Inc.2004-09-28
CERVICAL PLATE (K042317)Scient'X2004-09-24
ST360 SPINAL FIXATION SYSTEM (K041925)Zimmer Spine, Inc.2004-09-24
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE (K042312)Smith & Nephew, Inc.2004-09-24
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K042019)Howmedica Osteonics Corp.2004-09-24
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS (K041591)Howmedica Osteonics Corp.2004-09-23
MODIFICATION TO VBR SPINAL SYSTEM (K041722)Depuy Spine, Inc.2004-09-23
ARTELON SPACER CMC-1 (K040070)Artimplant AB2004-09-21
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR (K042100)Blackstone Medical, Inc.2004-09-20
BONE FUSION PLATE SYSTEM (K042205)Wrightmedicaltechnologyinc2004-09-20
ORION ANTERIOR CERVICAL PLATING SYSTEM (K042235)Medtronic Sofamor Danek2004-09-17
HYPROCURE SUBTALAR IMPLANT SYSTEM (K042030)Graham Medical Technologies, LLC2004-09-16
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