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Orthopedic

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

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RecordFirmDate
OPUS TWINLOCK KNOTLESS FIXATION DEVICE (K071374)Arthrocare Corp.2007-08-02
MODIFICATION TO: VIPER SPINE SYSTEM (K071860)Depuy Spine, Inc.2007-08-01
CERAMIC BALL HEADS, 28, 32 AND 36 MM (K070928)Plus Orthopedics AG2007-08-01
GRAFT CONTAINMENT DEVICE (K070148)Nuvasive, Inc.2007-07-31
SUBTALAR IMPLANT (K071498)Biomet Sports Medicine, Inc.2007-07-31
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES (K071856)Zimmer, Inc.2007-07-30
MBCP+ (K063527)Biomatlante2007-07-30
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM (K071105)Osteomed LP2007-07-30
VU E*POD VERTEBRAL BODY REPLACEMENT (K071031)Theken Spine, LLC2007-07-30
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) (K063275)Terray Corp.2007-07-27
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE (K070598)Memometal Technologies2007-07-26
BIOMET VARIABLE LOCKING PLATE SYSTEM (K071325)Biomet Trauma2007-07-26
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS (K071784)DePuy Orthopaedics, Inc.2007-07-25
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS (K071174)Abbott Spine, Inc.2007-07-25
CERMET III ACETABULAR CUP SYSTEM (K071583)Implants International, Ltd.2007-07-25
GSO GS1 SPINAL SYSTEM (K070966)Gold Standard Orthopaedics, LLC2007-07-20
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM (K071147)Nexa Orthopedics, Inc.2007-07-20
STRYKER PEEK TWINLOOP TAC (K070882)Stryker Endoscopy2007-07-20
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS (K071676)Exactech, Inc.2007-07-19
ACUMED CONGRUENT BONE PLATE SYSTEM (K071715)Acumed, LLC2007-07-18
TRIPORE, MODELS HA, BP90, BP15 (K070132)Orthogem Limited2007-07-13
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES (K070555)Orthopro, LLC2007-07-13
TRILOGY LONGEVITY CONSTRAINED LINER (K071718)Zimmer, Inc.2007-07-13
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM (K070631)Stryker Spine2007-07-13
DYNASTY ACETABULAR SYSTEM (K070785)Wrightmedicaltechnologyinc2007-07-11
BENVENUE VCF OSTEO COIL SYSTEM (K070293)Benvenue Medical, Inc.2007-07-10
ATLANTIK (K070794)Medical Biomat2007-07-10
EXPEDIUM SPINE SYSTEM (K063772)Depuy Spine, Inc.2007-07-10
QWIX POSITIONING SCREW (K071639)Newdeal Sas2007-07-09
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE (K071264)Synthes (Usa)2007-07-09
BIOMET VISION FOOTRING SYSTEM (K071395)Biomet Manufacturing Corp2007-07-09
PILLAR PEDICLE SCREW SYSTEM (K071743)The 4th Column, LLC2007-07-06
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON (K071107)Zimmer, Inc.2007-07-06
ZIMMER SEGMENTAL SYSTEM (K070978)Zimmer, Inc.2007-07-03
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER (K071155)Science For Biomaterials2007-07-03
QUANTUM SPINAL SYSTEM (K070973)Pioneer Surgical Technology2007-07-03
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER (K071569)Biomet, Inc.2007-07-02
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K071497)Atlas Spine, Inc.2007-06-29
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW (K071177)Arthrex, Inc.2007-06-29
SPACE 360 DELIVERY SYSTEM (K070351)Dfine, Inc.2007-06-29
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION (K071090)Zimmer Trabecular Metal Technology2007-06-29
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD (K071257)Depuy Mitek, A Johnson & Johnson Company2007-06-29
EXPEDIUM 4.5MM SPINE SYSTEM (K071495)Depuy Spine, A Johnson & Johnson Company2007-06-29
MODIFICATION TO:SBI RINGFIX (K071394)Small Bone Innovations, Inc.2007-06-29
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (K071053)Biomet, Inc.2007-06-29
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT (K070786)Theken Spine, LLC2007-06-28
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM (K063670)Medtronic Sofamor Danek2007-06-28
OSSIPRO BONE SUBSTITUTE MATERIAL (K062630)Etex Corp.2007-06-28
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849)DePuy Orthopaedics, Inc.2007-06-26
SMALL STATURE SPACERS (K063393)Biomet Spine2007-06-25
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM (K071184)Synthes (Usa)2007-06-22
ARX-LINK CROSS CONNECTOR (K070995)Life Spine2007-06-22
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA (K071064)Ascension Orthopedics, Inc.2007-06-22
AOS TIBIAL NAIL (K070444)Advanced Orthopaedic Solutions, Inc.2007-06-14
CANNULATED SCREW (K070617)Fournitures Hospitalieres Industrie2007-06-14
LOWTOP PEDICLE SCREW SYSTEM (K070933)Sanacor2007-06-13
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM (K071376)Vertebron, Inc.2007-06-13
ALLEZ SPINE CROSS CONNECTORS (K070460)Allez Spine, LLC2007-06-11
MODIFICATION TO: INTERPLATE VBR SYSTEM (K071372)Rsb Spine, LLC2007-06-11
ISSYS LP SPINAL FIXATION SYSTEM (K070281)Custom Spine, Inc.2007-06-11
ALTIVA CLASSIC ACP SYSTEM (K070891)Altiva Corp.2007-06-11
SYNAPSE SYSTEM (K070573)Synthes Spine Co.Lp2007-06-08
OPTECURE; OPTECURE + CCC (K063685)Exactech, Inc.2007-06-07
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS (K070695)Zimmer, Inc.2007-06-07
ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (K070756)Smith & Nephew, Inc.2007-06-06
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES (K070946)Synthes (Usa)2007-06-06
TRIATHLON TS KNEE SYSTEM (K070095)Howmedica Osteonics Corp.2007-06-01
ARTELON CMC SPACER ARTHRO (K061954)Artimplant AB2007-06-01
COLUMBUS TOTAL KNEE SYSTEM AS (K071220)Aesculap Implant Systems, Inc.2007-06-01
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER (K070864)Biomet Osteobiologics2007-06-01
COPIOS BONE VOID FILLER SPONGE AND PASTE (K071237)Kensey Nash Corp.2007-06-01
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE (K071206)Apatech , Ltd.2007-05-31
SBI DISTAL RADIUS VOLAR PLATING SYSTEM (K070793)Small Bone Innovations, Inc.2007-05-30
VISTA -S DEVICE (K070382)Zimmer Trabecular Metal Technology2007-05-30
THEKEN ATOLL CERVICO-THORACIC SYSTEM (K070638)Theken Spine, LLC2007-05-30
OSSTAPLE, OSSPLATE, OSSFORCE (K061385)Biomedical Enterprises, Inc.2007-05-30
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM (K061943)Anatomica AB2007-05-25
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES (K070561)Teleflex Medical2007-05-25
METAL HEMI IMPLANT (K071243)Orthopro, LLC2007-05-23
VITALITY HIP SYSTEM MODEL#420 (K070050)Encore Medical L.P.2007-05-23
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM (K070295)Trinity Orthopedics, LLC2007-05-21
ROC LUMBAR SYSTEM (K063668)Alphatec Spine, Inc.2007-05-18
COFIELD TOTAL SHOULDER SYSTEM (K070565)Smith & Nephew, Inc.2007-05-18
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS (K071117)DePuy Orthopaedics, Inc.2007-05-18
NEXFIX COMPRESSION STAPLE (K070688)Nexa Orthopedics, Inc.2007-05-18
MODIFICATION TO BILOK ST SCREW (K071115)Biocomposites, Ltd.2007-05-17
MODIFICATION TO BILOK SCREW (K071091)Biocomposites, Ltd.2007-05-17
UNIVERSAL TAPER DELTA FEMORAL HEAD (K070885)Howmedica Osteonics Corp.2007-05-16
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM (K063764)Southern Spine, LLC2007-05-16
SMITH & NEPHEW KINSA RC SUTURE ANCHOR (K070908)Smith & Nephew Inc., Endoscopy Division2007-05-16
STRYKER PEEK ZIP SUTURE ANCHOR (K070758)Stryker Endoscopy2007-05-16
IOS EXTERNAL FIXATOR, MODEL 2-0-0 (K070724)Intelligent Orthopaedics, Ltd.2007-05-16
DURACON X3 CS TIBIAL INSERT (K070883)Howmedica Osteonics Corp.2007-05-11
ALLOFIX PUSH-IN ANCHOR (K070347)Musculoskeletal Transplant Foundation2007-05-11
ASNIS MICRO CANNULATED SCREW (K071092)Howmedica Osteonics Corp.2007-05-11
PRO-DENSE BONE VOID FILLER (K070437)Wrightmedicaltechnologyinc2007-05-09
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 (K063584)Regeneration Technologies, Inc.2007-05-09
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM (K070994)Depuy Spine, Inc.2007-05-09
METASURG SUBTALAR IMPLANT (K070441)Metasurg2007-05-08
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