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Orthopedic

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

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RecordFirmDate
PALACOS R+G PRO (K142157)Heraeus Medical GmbH2014-09-05
FORTICORE (K140280)Nanovis, LLC2014-09-05
XENCO MEDICAL CERVICAL INTERBODY SYSTEM (K140786)Xenco Medical, LLC2014-09-03
ARTHREX IBALANCE TKA SYSTEM (K141635)Arthrex, Inc.2014-09-03
GENERAL SPINAL SYSTEM (K134011)Changzhou Dean Medical Instrument Co, Ltd.2014-09-03
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH (K141840)Zimmer, Inc.2014-09-03
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM (K133911)Genesys Spine2014-09-03
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) (K141078)Orthofix Srl2014-09-02
RENOVIS CEMENTED HIP SYSTEM (K141370)Renovis Surgical Technologies, Inc.2014-09-02
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS (K140735)Microport Orthopedics, Inc.2014-08-29
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)Synthes (USA) Products, LLC2014-08-29
DISTAL ELBOW PLATING SYSTEM (K140892)Skeletal Dynamics, LLC2014-08-28
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION (K142135)Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014-08-28
INFRONT LUMBAR INTERBODY FUSION SYSTEM (K141443)Infront Medical, LLC2014-08-28
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET (K141821)Exactech, Inc.2014-08-28
CONFIRM BIOACTIVE (K133678)Globus Medical, Inc.2014-08-26
VERTIFORM POSTERIOR FIXATION SYSTEM (K141291)Next Orthosurgical2014-08-26
ORTHOHUB EXTERNAL FIXATOR SOFTWARE (K140550)Orthohub, Inc.2014-08-25
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE (K140946)Novabone Products, LLC2014-08-22
MERCURY SPINAL SYSTEM (K141372)Spinal Elements, Inc.2014-08-22
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS (K141509)Medos Sarl2014-08-22
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML (K141930)Osseon, LLC2014-08-21
TENSYN BAND, TENSYN FRACTURE PLATES (K141264)Dallen Medical, Inc.2014-08-21
ROMEO 2 PAD POSTERIOR AXIAL DEVICE (K141508)Spineart2014-08-21
VALOR HINDFOOT FUSION NAIL SYSTEM (K142121)Wrightmedicaltechnologyinc2014-08-21
SMITH & NEPHEW DISPOSABLE FIN PUNCH (K141585)Smith & Nephew, Inc.2014-08-21
ORTHOHELIX STAPLE SYSTEM (K142148)Orthohelix Surgical Designs, Inc.2014-08-21
INTRAOSSEOUS FIXATION SYSTEM (K141004)Orthohelix Surgical Designs, Inc.2014-08-21
M.U.S.T PEDICLE SCREW SYSTEM (K141988)Medacta International2014-08-19
M.U.S.T. EXTENSION (K141044)Medacta International2014-08-18
BIOLOX DELTA CERAMIC OPTION HEADS (K141653)Biomet, Inc.2014-08-18
EXACTECH CERVICAL SPACER SYSTEM (K141129)Exactech, Inc.2014-08-15
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS (K132049)Choicespine2014-08-15
ARTHREX ANKLE FUSION PLATING SYSTEM (K141735)Arthrex, Inc.2014-08-15
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS (K140508)Zimmer, Inc.2014-08-14
KIVA VCF TREATMENT SYSTEM (K141141)Benvenue Medical, Inc.2014-08-14
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES (K141517)Zimmer, Inc.2014-08-13
ARTHREX FIBERTAK SUTURE ANCHOR (K140476)Arthrex, Inc.2014-08-13
FIBERGRAFT BG MORSELS (K141956)Prosidyan, Inc.2014-08-13
ZIMMER PERIARTICULAR LOCKING SYSTEM (K141734)Zimmer, Inc.2014-08-13
LATERAL VBR SYSTEM (K140563)Nu Vasive, Incorporated2014-08-07
Z-LINK CERVICAL (K141005)Zavation, LLC2014-08-07
VARIAX 2 SYSTEM (K141992)Stryker Trauma AG2014-08-07
AAP LOQTEC CLAVICLE PLATES 2.7/3.5 (K141823)Aap Implantate AG2014-08-07
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM (K141241)Synthes (USA) Products, LLC2014-08-07
MINIMA S SYSTEM (K141327)Lima Corporate S.P.A.2014-08-06
AEQUALIS REVERSED SHOULDER PROSTHESIS (K140478)Tornier S.A.S.2014-08-06
CD HORIZON SPINAL SYSTEM (K141494)Medtronic Sofamor Danek USA, Inc.2014-08-06
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (K141056)Stryker Orthopaedics2014-08-05
SKAFFOLD NMX BONE VOID FILLER (K132211)Skeletal Kinetics, LLC2014-08-04
AS20 COMPOSITE GRAFT (K141746)Wrightmedicaltechnologyinc2014-08-04
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP (K141841)Integra Lifescience Corportation2014-08-01
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT (K132912)In2bones Sas2014-07-30
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM (K141011)Wrightmedicaltechnologyinc2014-07-30
K2M MODULAR HOOKS (K133402)K2m, Inc.2014-07-30
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT (K140883)Biomet, Inc.2014-07-30
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS (K140302)Exactech, Inc.2014-07-30
ALPINE HIP STEM; ALPINE HA HIP STEM (K141001)Ortho Development2014-07-30
CAMERA ENABLED PROBE (K141119)Trice Medical, Inc.2014-07-29
Kangli Locking Plate System (K133840)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-07-29
PEDILOC FRAGMENT SYSTEM (K140431)OrthoPediatrics Corp.2014-07-29
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM (K133947)X-Spine Systems, Inc.2014-07-29
ALTEON 6.5MM BONE SCREWS (K141797)Exactech, Inc.2014-07-29
HUMELOCK II CEMENTED SHOULDER SYSTEM (K140071)Fx Solutions2014-07-28
COROENT SMALL INTERBODY SYSTEM (K140921)Nu Vasive, Incorporated2014-07-28
COROENT XL-F SYSTEM (K140479)Nu Vasive, Incorporated2014-07-28
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM (K140770)Nu Vasive, Incorporated2014-07-25
LINOS MOH HAND PLATING SYSTEM (K141489)KLS Martin L.P.2014-07-24
PLIF LITE AND TLIF LITE (K132907)Sintea Plustek2014-07-24
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE (K141711)Pontis Orthopaeeics, LLC2014-07-24
C-JAWS CERVICAL COMPRESSIVE STAPLE (K133906)Medicrea International2014-07-24
ORTHO SOLUTIONS ULTOS PLATING SYSTEM (K141784)Ortho Solutions Limited2014-07-23
IFUSE IMPLANT SYSTEM (K141049)SI-BONE, Inc.2014-07-23
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES (K132820)Vilex, Inc.2014-07-23
CASPIAN SPINAL SYSTEM (K141284)K2m, Inc.2014-07-23
VELOXTM INTERBODY FUSION SYSTEM (K140864)U&I Corp.2014-07-22
VARIAX ELBOW PLATING SYSTEM (K141677)Stryker Trauma AG2014-07-22
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW (K140876)Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014-07-22
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE (K133370)Signature Orthopaedics Pty Limited2014-07-22
BIOSURE HEALICOIL PK INTERFERENCE SCREW (K140879)Smith & Nephew, Inc.2014-07-21
EXCIA TOTAL HIP SYSTEM (K140915)Aesculap Implant Systems, LLC2014-07-21
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS (K141219)Biomet Manufacturing Corp2014-07-18
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE (K132732)Medyssey USA, Inc.2014-07-18
ARTHREX PIP DART (K141577)Arthrex, Inc.2014-07-18
VARIAX DISTAL RADIUS PLATING SYSTEM (K141430)Stryker Leibinger GmbH & Co KG2014-07-18
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM (K140082)Tornier S.A.S.2014-07-18
NUVIS ARTHROSCOPE (K140903)Integrated Endoscopy, Inc.2014-07-17
SHILLA GROWTH GUIDANCE SYSTEM (K140750)Medtronic Sofamor Danek USA, Inc.2014-07-17
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC (K140844)Synergy Biomedical, Inc.2014-07-16
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) (K140142)Choicespine, LP2014-07-16
ACCULIF TL AND PL CAGE (K141217)Stryker Corporation2014-07-16
MILESTONE SPINAL SYSTEM (K133053)Weigao Orthopaedic Device Co., Ltd.2014-07-15
GMK SPHERE EXTENSION (K140826)Medacta International2014-07-15
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE (K133813)Expanding Orthopedics, Inc.2014-07-15
PFX SPINOUS PROCESS FIXATION SYSTEM (K132765)Innovasis, Inc.2014-07-14
CONSENSUS VITALITE TIBIAL INSERT (K133919)Consensus Orthopedics, Inc.2014-07-14
CD HORIZON SPINAL SYSTEM (K141605)Medtronic Sofamor Danek USA, Inc.2014-07-14
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM (K141301)Orthohelix Surgical Designs, Inc.2014-07-11
INSTAFIX SHAPE MEMORY FIXATION SYSTEM (K141550)Ot Medical2014-07-11
EXPRT REVISION KNEE (K140830)Encore Medical L.P.2014-07-11
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