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Orthopedic

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

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RecordFirmDate
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR (K070773)Axya Medical, Inc.2007-10-11
TRIATHLON PKR SYSTEM (K071881)Howmedica Osteonics Corp.2007-10-09
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM (K072546)Depuy Spine, Inc.2007-10-05
ZIMMER DTO IMPLANT (K071879)Zimmer Spine, Inc.2007-10-05
MODIFICATION TO OASYS SYSTEM (K072568)Stryker Spine2007-10-05
MODIFICATION TO SPACE CPSXL BONE CEMENT (K072496)Dfine, Inc.2007-10-05
SMALL BONE WEDGE (K070592)Wrightmedicaltechnologyinc2007-10-05
REFLECTION, TANDEM UNIPOLAR (K071160)Smith & Nephew, Inc.2007-10-05
Optima ZS Transition Screw (K071880)Zimmer Spine, Inc.2007-10-05
NIKO CORPECTOMY SPACER (K072465)Globus Medical, Inc.2007-10-04
DEPUY DELTA TS CERAMIC FEMORAL HEADS (K071830)DePuy Orthopaedics, Inc.2007-09-28
MODIFICATION TO TSRH SPINAL SYSTEM (K072429)Medtronic Sofamor Danek2007-09-28
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS (K072095)Synthes (Usa)2007-09-27
RELIANCE VBS SYSTEM (K063637)Reliance Medical Systems, LLC2007-09-27
OSSIFUSE BONE SUBSTITUTE MATERIAL (K072355)Etex Corp.2007-09-26
MODIFICATION TO PASSMED SPINAL SYSTEM (K070276)Medicrea Technologies2007-09-21
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (K072384)Kensey Nash Corp.2007-09-21
BIOMET FEMORAL LOCKING NAIL SYSTEM (K072161)Biomet Manufacturing Corp2007-09-20
CONFORMIS METAL BACKED TIBIAL COMPONENT (K072368)Conformis, Inc.2007-09-20
S4 SPINAL SYSTEM (K071945)Aesculap Implant Systems2007-09-20
HARPOON SUTURE ANCHOR (K071816)Biomet Sports Medicine, Inc.2007-09-20
MODIFICATION TO SPINAL USA VBR SYSTEM (K070922)Spinal USA2007-09-19
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS (K071071)Smith & Nephew, Inc.2007-09-19
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC (K071922)Rsb Spine, LLC2007-09-18
MODIFICATION TO:TSRH SPINAL SYSTEM (K072317)Medtronic Sofamor Danek USA, Inc.2007-09-18
EXPEDIUM SPINE SYSTEM (K070387)Depuy Spine, Inc.2007-09-18
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE (K072184)Orthovita, Inc.2007-09-18
BONEMEDIK, AND BONEMEDIK-S (K070897)Meta Biomed Co., Ltd.2007-09-17
SLEEVE AND BUTTON SOFT TISSUE DEVICES (K071704)Biomet Sports Medicine, Inc.2007-09-17
MONDEAL DISTAL RADIUS SYSTEM (K071798)Mondeal Medical Systems GmbH2007-09-17
LANX SPINAL FIXATION SYSTEM (K071877)Lanx, LLC2007-09-17
INQU (K071428)Isto Technologies, Inc.2007-09-17
MONDEAL HAND CONTOUR SYSTEM (K071797)Mondeal Medical Systems GmbH2007-09-17
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS (K071157)Stryker Endoscopy2007-09-17
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY (K071499)Aesculap Implant Systems, Inc.2007-09-14
CAPLESS LI PEDICLE SCREW SYSTEM (K072282)X-Spine Systems, Inc.2007-09-14
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K070742)Medtronic Sofamor Danek2007-09-14
STRYKER MODULAR HIP SYSTEM (K071082)Howmedica Osteonics Corp.2007-09-13
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C (K071437)KARL STORZ Endoscopy-America, Inc.2007-09-12
DELTA XTEND REVERSE SHOULDER MODULAR STEM (K071379)DePuy Orthopaedics, Inc.2007-09-11
TRIBONE 80 (K071121)Biomatlante2007-09-11
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS (K070554)DePuy Orthopaedics, Inc.2007-09-11
CORIN ADAPTOR SLEEVE (K071471)Howmedica Osteonics Corp.2007-09-10
SBI TWISTOFIX (K071541)Small Bone Innovations, Inc.2007-09-10
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER (K071577)Biomet Microfixation, Inc.2007-09-06
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K070282)Endius, Inc.2007-09-06
NEXGEN PROLONG ALL-POLY PATELLA (K072281)Zimmer, Inc.2007-09-06
NEXGEN TRABECULAR METAL TIBIAL TRAY (K072160)Zimmer, Inc.2007-09-05
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 (K072183)Zimmer Spine, Inc.2007-09-05
ACME TALON PEDICLE SCREW (K071824)Acme Spine, LLC2007-09-04
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) (K071863)Bioretec, Ltd.2007-08-31
DOMINATOR (K072127)Biocomposites, Ltd.2007-08-31
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 (K070754)Zimmer Trabecular Metal Technology2007-08-31
VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K063453)Elite Surgical Supplies (Pty), Ltd.2007-08-30
LDR SPINE ROI-T SYSTEM (K072132)Ldr Spine USA2007-08-30
SBI FOREFOOT SET (K063635)Small Bone Innovations, Inc.2007-08-29
AAP APS SYSTEM (K071852)Aap Implantate AG2007-08-29
SBI ARTFIX (K071656)Small Bone Innovations, Inc.2007-08-27
STRYKER SPINE XIA III SPINAL SYSTEM (K071373)Stryker Spine2007-08-27
GSO GS1 SPACER (K071274)Gold Standard Orthopedics, LLC2007-08-24
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476)Synthes (Usa)2007-08-24
LATITUDE ELBOW PROTHESIS (K070787)Tornier2007-08-24
CORAL PEDICLE SCREW SYSTEM (K070962)Theken Spine, LLC2007-08-22
PSS SYSTEM (K071438)Spinal USA2007-08-21
CONMED LINVATEC XO BUTTON (K070780)Conmed Linvatec2007-08-21
TITANIUM HIP TOOL LOCKING PLATE (K072175)Orthopedic Sciences, Inc.2007-08-21
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) (K070981)Aesculap Implant Systems, Inc.2007-08-21
ARTHREX UNIVERS II SHOULDER PROSTHESIS (K071032)Arthrex, Inc.2007-08-20
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM (K071380)Alphatec Spine, Inc.2007-08-20
DEPUY GCK TIBIAL COMPONENTS (K070267)DePuy Orthopaedics, Inc.2007-08-17
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM (K071790)Smith & Nephew, Inc.2007-08-17
BIORAPTOR 2.3 PK SUTURE ANCHOR (K071586)Smith & Nephew Inc., Endoscopy Division2007-08-17
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (K061880)Isotis NV2007-08-15
MODIFICATION TO SCORPIO NRG KNEE SYSTEM (K071991)Howmedica Osteonics Corp.2007-08-15
REVERTO 55 AND 37 SHAPE MEMORY STAPLES (K071477)Core Essence Orthopaedics, LLC2007-08-15
MINI TIGHTROPE FT REPAIR KIT (K071978)Arthrex, Inc.2007-08-15
APEX HCLA ACETABULAR CUP LINERS (K062489)Omnilife Science2007-08-15
LANX DEFORMITY SYSTEM (K071633)Lanx, LLC2007-08-15
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER (K071738)Exactech, Inc.2007-08-15
GRAFTLOCK SCREW, ST SCREW (K071952)Biocomposites, Ltd.2007-08-14
T2 XVBR SPINAL SYSTEM (K071033)Medtronic Sofamor Danek2007-08-14
IFS BONE FIXATION DEVICES (K071035)Internal Fixation Systems, Inc.2007-08-13
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X (K071520)Core Essence Orthopaedics, LLC2007-08-10
HEALIX ANCHOR (K071481)Depuy Mitek, A Johnson & Johnson Company2007-08-09
ACUMED SMALL BONE LOCKING SYSTEM II (K071944)Acumed, LLC2007-08-09
PEEK KNOTLESS ANCHORS (K070389)Biomet Sports Medicine, Inc.2007-08-09
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K071563)Smith & Nephew, Inc.2007-08-08
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM (K070341)Ldr Spine USA2007-08-08
DELTA SPINAL FUSION SYSTEM (K071857)Jemo Spine, LLC2007-08-08
SBI TITANIUM THREADED PIN (K071540)Small Bone Innovations, Inc.2007-08-08
NUVASIVE HELIX ACP SYSTEM (K071329)Nuvasive, Inc.2007-08-08
SBI RHEAD PLATING SYSTEM (K071549)Small Bone Innovations, Inc.2007-08-07
POLARIS BE RODS (K071377)Biomet Spine2007-08-06
NUVASIVE OCT SYSTEM (K071435)Nuvasive, Inc.2007-08-06
INION HEXALON BIODEGRADABLE ACL/PCL SCREW (K071464)Inion OY2007-08-03
C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K072040)Medicrea Technologies2007-08-03
INTRINSIC THERAPEUTICS FIXATION STAPLE (K071637)Intrinsic Therapeutics Incorporated2007-08-03
MODIFICATION TO: ARTHREX INTERFERENCE SCREW (K071176)Arthrex, Inc.2007-08-03
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES (K071417)DePuy Orthopaedics, Inc.2007-08-02
SBI STAFIX (K071479)Small Bone Innovations, Inc.2007-08-02
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