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Orthopedic

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

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RecordFirmDate
RAMPART-L (K133371)Spineology, Inc.2014-01-09
HAMMERLOCK 2 (K133520)Biomedical Enterprises, Inc.2014-01-09
MIDLINE (TM) (K133286)Centinel Spine, Inc.2014-01-09
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM (K133452)Emerge Medical2014-01-08
AXIA RADIAL HEAD SYSTEM (K132735)Imds (Innovative MEdical Device Systems) - Leis ME2014-01-07
D-RAD SMART PACK (K132296)Smith & Nephew, Inc.2014-01-07
ACUMED HAND PLATING SYSTEM (K132769)Acumed, LLC2014-01-06
DISTALOCK TIBIAL IM NAIL SYSTEM (K132830)Dgimed Ortho, Inc.2014-01-06
LATERAL SYNFIX (K131276)Synthes (USA) Products, LLC2014-01-06
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (K132733)Orthohelix Surgical Designs, Inc.2014-01-03
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (K131880)Spinefrontier, Inc.2014-01-03
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM (K133645)Medtronic Sofamor Danek USA, Inc.2014-01-03
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES (K133224)Conmed Corporation2014-01-03
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N (K133081)Advanced Orthopaedic Solutions, Inc.2013-12-31
MONUMENT SPACERS (K132559)Globus Medical, Inc.2013-12-30
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM (K132867)Cayenne Medical, Inc.2013-12-30
COMPRESSYN STAPLE (K132875)Dallen Medical, Inc.2013-12-30
REUNION RSA SHOULDER SYSTEM (K130895)Howmedica Osteonics Corp.2013-12-27
COROENT STERILE IMPLANTS SYSTEM (K132601)Nu Vasive, Incorporated2013-12-24
SIGNIFY BIOACTIVE (K130977)Globus Medical, Inc.2013-12-24
VELOX ANTERIOR CERVICAL PLATE SYSTEM (K131521)Spinecraft, LLC2013-12-24
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (K131724)Pioneer Surgical Technology, Inc.2013-12-24
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE (K132787)Aap Implantate AG2013-12-24
ASCOT (K132310)Backroads Consulting, Inc.2013-12-23
IDEAL (K132428)Jiangsu Ideal Medical Science & Technology Co., LT2013-12-20
CAPSTONE SPINAL SYSTEM (K133650)Medtronic Sofamor Danek USA, Inc.2013-12-20
GMK SHORT STEM (K133630)Medacta International2013-12-20
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM (K133052)Nuvasive, Inc.2013-12-20
INFIX ANTERIOR LUMBAR SYSTEM (K132790)Zimmer Spine, Inc.2013-12-20
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS (K133475)Nexxt Spine, LLC2013-12-19
M.U.S.T. EXTENSION (K132878)Medacta International2013-12-18
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION (K133440)Stryker Trauma AG2013-12-18
APTUS CANNULATED COMPRESSION SCREWS (K133460)Medartis AG2013-12-18
ARIX HAND LOCKING SYSTEM (K132876)Jeil Medical Corporation2013-12-18
PERFIX ILIAC SCREW SYSTEM (K132218)U&I Corporation2013-12-17
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL (K133188)Stryker Spine2013-12-17
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (K130652)Consensus Orthopedics, Inc.2013-12-17
ST360 DEGREES SPINAL FIXATION SYSTEM (K133291)Zimmer Spine, Inc.2013-12-17
ARTHREX IBALANCE TKA SYSTEM (K133342)Arthrex, Inc.2013-12-17
ZIMMER DISTAL RADIUS PLATING SYSTEM (K133246)Zimmer, Inc.2013-12-17
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS (K130073)Mikron Makina Sanayi VE Ticaret Ltd. Sti.2013-12-16
CORIN MINIHIP STEM (K131986)Corin USA2013-12-16
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM (K132910)Synthes USA Products, LLC2013-12-16
CORIN METAFIX HIP STEM (K131952)Corin USA2013-12-16
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM (K130913)Genesys Spine2013-12-13
CROSSCHECK PLATING SYSTEM (K132594)Solana Surgical, LLC2013-12-13
NORMED PELLEGRIN CALCANEUS STOP SCREW (K133035)Normed Medizin-Technik GmbH2013-12-13
VANGUARD XP KNEE SYSTEM (K132873)Biomet, Inc.2013-12-11
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM (K130317)Genesys Spine2013-12-11
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS (K130708)Smith & Nephew, Inc.2013-12-11
CERTEX OCT SPINAL IMPLANT SYSTEM (K133094)X-Spine Systems, Inc.2013-12-11
CLYDESDALE SPINAL SYSTEM (K132897)Medtronic Sofamor Danek, Inc.2013-12-11
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (K133039)Mako Surgical Corporation2013-12-10
K7 LUMBAR SPACERS (K133126)K7, LLC2013-12-09
EXOSHAPE DUO SOFT TISSUE FASTENER (K132783)MedShape, Inc.2013-12-09
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K133289)Ellipse Technologies, Inc.2013-12-09
CD HORIZON SPINAL SYSTEM (K132328)Medtronic Sofamor Danek USA, Inc.2013-12-06
STAXX(R) SYSTEM (K133207)Spine Wave, Inc.2013-12-06
LIGAPASS (K132395)Medicrea International2013-12-06
CROSSTREES PVA POD (K133372)Crosstrees Medical, Inc.2013-12-06
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT (K133376)Tornier, Inc.2013-12-05
AEQUALIS REVERSED SHOULDER PROSTHESIS (K132285)Tornier S.A.S.2013-12-05
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K132640)Conformis, Inc.2013-12-05
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE (K130467)MedShape, Inc.2013-12-05
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM (K132994)Corelink, LLC2013-12-05
PERIMETER C SPINAL SYSTEM (K132584)Medtronic Sofamor Danek USA, Inc.2013-12-04
1ST MTP PLATE (K133437)Osteomed2013-12-02
PIEZOSURGERY FLEX (K132848)Mectron S.P.A.2013-11-29
ESPIN SYSTEM (K133061)Nlt Spine, Ltd.2013-11-27
TITLE 2 POLYAXIAL SPINAL SYSTEM (K133086)Zimmer Spine, Inc.2013-11-27
ZIP MIS INTERSPINOUS FUSION SYSTEM (K133091)Aurora Spine2013-11-27
ARCHON ANTERIOR CERVICAL PLATE SYSTEM (K131025)Nuvasive, Inc.2013-11-27
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) (K131591)Pega Medical, Inc.2013-11-27
TRIATHLON TRITANIUM METAL-BACKED PATELLA (K132624)Stryker Orthopaedics2013-11-26
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298)Exactech, Inc.2013-11-26
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM (K132740)Spinefrontier, Inc.2013-11-26
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132504)Corelink, LLC2013-11-25
ANAX 5.5 SPINAL SYSTEM (K132101)U&I Corporation2013-11-25
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE (K132029)Spinal USA2013-11-25
CD HORIZON SPINAL SYSTEM (K132639)Medtronic Sofamor Danek USA, Inc.2013-11-25
ARTHREX COMPRESSION FT SCREWS (K132217)Arthrex, Inc.2013-11-25
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM (K132884)Zimmer Spine, Inc.2013-11-25
CRESCENT SPINAL SYSTEM (K133216)Medtronic Sofamor Danek, Inc.2013-11-22
SP-FIX SPINOUS PROCESS FIXATION PLATE (K132191)Globus Medical, Inc.2013-11-22
APEX SPINE SYSTEM (K132603)Spinecraft, LLC2013-11-20
AFFIX II SPINOUS PROCESS PLATE SYSTEM (K132411)Nu Vasive, Incorporated2013-11-20
EVEREST SPINAL SYSTEM (K132757)K2m, Inc.2013-11-20
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW (K132893)Icon Orthopaedic Concepts Dba Edge Orthopaedics2013-11-20
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (K131377)Arthrosurface, Inc.2013-11-19
A.L.P.S. CALCANEAL PLATING SYSTEM (K132898)Biomet Manufacturing Corp2013-11-19
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) (K132968)Stryker Spine2013-11-18
FLOWER ANKLE PLATING SET (K133102)Flower Orthopedics Corporation2013-11-18
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 (K131782)Aap Implantate AG2013-11-18
INTEGRITY SPINE CORE SYSTEM (K132718)Integrity Spine2013-11-18
TENSYN BAND (K131850)Dallen Medical, Inc.2013-11-15
IDYS(TM) C (K130853)Clariance2013-11-13
SPECTRUM SPINE SPINOUS PROCESS DEVICE (K130066)Spectrum Spine IP Holdings, LLC2013-11-12
HUMELOCK II CEMENTLESS SHOULDER SYSTEM (K130759)Fx Solutions2013-11-09
CAYMAN MI PLATE SYSTEM (K131533)K2m, Inc.2013-11-09
PASS LP SPINAL SYSTEM (K132574)Medicrea International2013-11-08
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