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Orthopedic

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

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RecordFirmDate
RANGE/MESA/DENALI SPINAL SYSTEM (K140765)K2m, Inc.2014-07-10
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW (K141417)Wrightmedicaltechnologyinc2014-07-09
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM (K140417)Medtronic Sofamor Danek, Inc.2014-07-09
BIOFOAM BONE WEDGE (K140531)Wrightmedicaltechnologyinc2014-07-09
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY (K140643)Depuy Mitek, A Johnson and Johnson Company2014-07-08
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (K141228)Advanced Orthopaedic Solutions, Inc.2014-07-08
RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811)Mako Surgical Corp.2014-07-08
ARTHREX FRACTURE PLATES AND SCREWS (K141478)Arthrex, Inc.2014-07-08
VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION (K133784)Zimmer Trabecular Metal Technology2014-07-07
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL (K140324)Depuy Mitek, A Johnson and Johnson Company2014-07-07
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG (K140902)Biomet, Inc.2014-07-03
NORMED VARIO SUBTALAR SCREW (K140962)Normed Nedizin Technik GmbH2014-07-03
POROUS COATED COMPREHENSIVE FRACTURE STEMS (K140652)Biomet Manufacturing Corp2014-07-03
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM (K133835)Arthrosurface, Inc.2014-07-03
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE (K140055)Titan Spine, LLC2014-07-02
AP EXPANDABLE XLIF SYSTEM (K140162)Nuvasive, Inc.2014-07-02
SKYHAWK LATERAL PLATE SYSTEM (K140260)Orthofix, Inc.2014-07-02
FLOW-NAIL (K140601)Flow-Fx, LLC2014-07-02
ALTERA SPACER (K140411)Globus Medical, Inc.2014-07-01
CASPIAN OCT SPINAL SYSTEM (K133288)K2m, Inc.2014-07-01
EXACTECH TAPERED WEDGE FEMORAL STEM (K140674)Exactech, Inc.2014-06-30
DELTA TT ACETABULAR SYSTEM (K141395)Lima Corporate S.P.A.2014-06-30
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K140833)Conformis, Inc.2014-06-30
MBD PLATE SYSTEM (K141045)Mbd Medical, LLC2014-06-30
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM (K133575)Spinevision S.A.2014-06-30
PRECICE TRAUMA NAIL SYSTEM (K141447)Ellipse Technologies, Inc.2014-06-30
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (K140701)Novosource, Inc.2014-06-27
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K141002)Visionsense, Ltd.2014-06-26
KANGLI PEDICLE SCREW SPINAL SYSTEM (K140053)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-06-26
DIAMOND RATTLESNAKE SYSTEM (K133194)Eminent Spine2014-06-26
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS (K133579)Pontis Orthopaedics, LLC2014-06-26
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS (K141376)Nexxt Spine, LLC2014-06-26
COROENT THORACOLUMBAR IMPLANTS (K140659)Nu Vasive, Incorporated2014-06-26
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM (K141397)Precision Spine, Inc.2014-06-26
APTUS ULNA SHORTENING 2.5 (K141232)Medartis AG2014-06-23
ENCOMPASS 10/12 HIP STEM (K132697)Ortho Development Corp.2014-06-20
AXSOS 3 TI LOCKING PLATE SYSTEM (K141121)Stryker Trauma AG2014-06-20
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM (K141204)Stryker Trauma AG2014-06-20
OSSEOFLEX SB (K140937)Osseon, LLC2014-06-19
COSMOLOCK PEDICLE SCREW SYSTEM (K140678)Kalitec Direct, LLC2014-06-19
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM (K141029)Tornier, Inc.2014-06-18
U2 FEMORAL COMPONENT, CR, CEMENTED (K140073)United Orthopedic Corp.2014-06-16
U2 FEMORAL COMPONENT, CR, POROUS COATED (K140075)United Orthopedic Corp.2014-06-13
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL (K140759)Medos International SARL2014-06-13
ACUMED HAND FRACTURE SYSTEM (K141383)Acumed, LLC2014-06-13
META-C CERVICAL PLATE (K140361)Medacta International2014-06-12
MASTERSL FEMORAL STEM (K140975)Lima Corporate S.P.A.2014-06-10
CHESAPEAKE SPINAL SYSTEM (K133494)K2m, Inc.2014-06-10
EMERGE EXTERNAL FIXATION SYSTEM (K140675)Emerge Medical, Inc.2014-06-10
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK (K141259)Depuy Mitek, A Johnson & Johnson Company2014-06-10
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM (K140357)Orthopaedic Implant Company2014-06-09
RSP HUMERAL SOCKET INSERT (K141006)Djo Global2014-06-05
BN LUMBAR CAGE SYSTEM (K140564)Medyssey USA, Inc.2014-06-05
STERISPINE PS (K140802)Safe Orthopaedics2014-06-04
BIOMET CANNULATED SCREW SYSTEM (K140891)Biomet, Inc.2014-06-03
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 (K140226)Science For Biomaterials2014-06-03
SMR TT METAL BACK GLENOID (K133349)Lima Corporate S.P.A.2014-06-03
RANGE SPINAL SYSTEM (K141147)K2m, Inc.2014-06-03
COMPRESSYN STAPLE (K140358)Dallen Medical, Inc.2014-06-02
ASPIRON ACP SYSTEM (K140234)U&I Corp.2014-06-02
SCHOELLY ARTHROSCOPE (K133682)Scholly Fiberoptic GmbH2014-06-02
VIRAGE OCT SPINAL FIXATION SYSTEM (K133556)Zimmer Spine, Inc.2014-06-02
PLS (POSTERIOR LUMBAR SYSTEM) (K140787)Sintea Plustek, LLC2014-05-30
PROFEMUR TL CLASSIC LONG NECK HIP STEMS (K140676)Microport Orthopedics, Inc.2014-05-30
OPTOSSOL COMPRESSION DEVICE SYSTEM (K140875)Genossis, LLC2014-05-30
AERO-AL LUMBAR CAGE SYSTEM (K133328)Stryker Corporation2014-05-30
DRIVE RAIL SYSTEM (K140822)Devise Ortho, Inc.2014-05-29
JOURNEY II BCS CONSTRAINED INSERTS (K140555)Smith & Nephew, Inc.2014-05-29
VARIAX 2 COMPRESSION PLATING SYSTEM (K140565)Stryker Trauma AG2014-05-29
PEEK CAGE FOR THE VERTEBRAL SPINE (K132852)Neoortho Produtos Ortopedicos S/A2014-05-29
S.E.A.L. FRACTURE FUSION TUBE (K140158)Dne, LLC2014-05-29
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE (K140509)Biomet Manufacturing, LLC2014-05-28
SKYHAWK INTERBODY FUSION SYSTEM (K140709)Orthofix, Inc.2014-05-27
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K140423)Conformis, Inc.2014-05-27
MYSPINE PEDICLE SCREW PLACEMENT GUIDES (K132788)Medacta International2014-05-23
EVEREST SPINAL SYSTEM (K140529)K2m, LLC2014-05-22
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER (K140027)Materialise NV2014-05-22
SALVATION 3DI PLATING SYSTEM (K140792)Wrightmedicaltechnologyinc2014-05-22
TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K140611)Zimmer Spine, Inc.2014-05-21
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM (K131609)Xiamen Double Engine Medical Material Co., Ltd.2014-05-21
SILC FIXATION SYSTEM (K133482)Globus Medical, Inc.2014-05-21
SOLUM IV BONE VOID FILLER (K132470)Spinesmith Partners, Llp2014-05-21
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K141023)Ellipse Technologies, Inc.2014-05-20
ACUMED SUTURE ANCHOR SYSTEM (K140925)Acumed, LLC2014-05-20
Y WIRE 2 (K140576)Safewire, LLC2014-05-20
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K140948)Spineart2014-05-20
OSTEOSPAN MORPHEUS (K132377)Biogennix, LLC2014-05-20
CS2 MULTI-HOLE ACETABULAR SHELL (K141043)Consensus Orthopedics, Inc.2014-05-19
KLASSIC KNEE TIBIAL STEM EXTENSION (K140942)Total Joint Orthopedics, Inc.2014-05-16
SALVATION BEAMS AND BOLTS SYSTEM (K140741)Wrightmedicaltechnologyinc2014-05-15
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW (K140952)Wrightmedicaltechnologyinc2014-05-15
SMITH & NEPHEW CANNULATED CAPTURED SCREW (K133662)Smith & Nephew, Inc.2014-05-15
SALVATION OSTEOPENIC SCREW (K140408)Wrightmedicaltechnologyinc2014-05-14
MSP METATARSAL SHORTENING SYSTEM (K140724)Nextremity Solutions, Inc.2014-05-14
MULTIFIX S KNOTLESS FIXATION SYSTEM (K140604)ArthroCare Corporation2014-05-14
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM (K132653)Neoortho Productos Orthopedicos S/A2014-05-14
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K133153)Spinefrontier, Inc.2014-05-14
ONE-PIECE PEEK FUSION IMPLANT (K140970)Mtp Solutions, LLC2014-05-13
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE (K140622)Biomet, Inc.2014-05-13
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K133378)Zimmer, Inc.2014-05-12
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