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Orthopedic

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

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RecordFirmDate
STALIF C(R) (K133200)Centinel Spine, Inc.2014-05-08
AAP LOQTEC(R) OLECRANON PLATE (K140607)Aap Implantate AG2014-05-08
EVOS MINI-FRAGMENT PLATING SYSTEM (K140814)Smith & Nephew, Inc.2014-05-07
TRUE SPINAL FUSSION SYSTEM (K133690)Innovative Surgical Designs2014-05-07
EXCELLA III-D SPINAL DEFORMITY SYSTEM (K140238)Innovasis, Inc.2014-05-07
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 (K140904)Encore Medical L.P.2014-05-06
INFILL CERVICAL (K140066)Pinnacle Spine Group, LLC2014-05-05
MATRIXRIB FIXATION SYSTEM (K133616)Synthes (USA) Products, LLC2014-05-02
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (K133418)Seaspine, Inc.2014-05-01
STABILIZATION SCREW (K131920)In2bones Sas2014-05-01
XCAGE INTERBODY FUSION SYSTEM (K133514)Ouroboros Medical2014-05-01
ORTHOPEDIC FIXATION SYSTEMS (K140216)Impact Medical, LLC2014-05-01
GENERAL SPINAL SYSTEM (K140229)Tianjin Walkman Biomaterial Co., Ltd.2014-04-29
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM (K133653)Medtronic Sofamor Danek USA, Inc.2014-04-28
PINIT SMALL BONE FUSION SYSTEM (K140617)Arthrosurface, Inc.2014-04-25
RELIANCE ANTERIOR CERVICAL PLATE (K140742)Reliance Medical Systems, LLC2014-04-25
INFINITY TOTAL ANKLE SYSTEM (K140749)Wrightmedicaltechnologyinc2014-04-25
OCTANE ELEVATE SPINAL IMPLANT SYSTEM (K123607)Exactech, Inc.2014-04-25
POLARIS SPINAL SYSTEM -TRANSLATION SCREW (K140123)Ebi, LLC2014-04-24
FORTRESS PEDICLE SCREW SYSTEM (K140010)Spineology, Inc.2014-04-23
ALAMO T (K140303)Alliance Partners, LLC2014-04-21
ORTHOSORB LS (K140625)Biomet, Inc.2014-04-18
JULIET OL (K140474)Spineart2014-04-18
MITEK ARTHROSCOPES (K133941)Medos International SARL2014-04-18
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES (K131612)GS Medical Co., Ltd.2014-04-18
MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K140375)Medtronic Sofamor Danek USA, Inc.2014-04-18
ZIP MIS INTERSPINOUS FUSION SYSTEM (K140715)Aurora Spine, Inc.2014-04-17
VARIAX 2 SYSTEM (K140769)Stryker Trauma AG2014-04-17
PARALOCK PLATING SYSTEM / TUFFNEK SCREW (K140397)Paragon 282014-04-17
ICONN ANSWER SUTURE ANCHOR (K132724)Iconn Orthopedics, LLC2014-04-17
AIS MODULIFT VBR SYSTEM (K133802)Aesculap Implant System, Inc.2014-04-17
SPEED ARC (K133270)Biomedical Enterprises, Inc.2014-04-17
INTESS CERVICAL CAGE SYSTEM (K133815)Kalitec Direct, LLC2014-04-16
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL (K132620)Pan Medical , Ltd.2014-04-16
COGENT MED-LIF (K132738)Cogent Spine, LLC2014-04-15
CERVICAL STAND ALONE SYSTEM (K132999)Orthofix, Inc.2014-04-14
DISCOSCOPES, CERVICAL ENDOSCOPES (K130778)Rz Medizintechnik GmbH2014-04-14
PICASSO II MIS SPINAL SYSTEM (K140219)Accel Spine2014-04-14
GIBRALT ROD-TO-ROD CROSS CONNECTORS (K140645)Exactech Sarasota2014-04-11
SPINEWORKS ANTERIOR LUMBAR DEVICE (K133340)Spineworks, LLC2014-04-11
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM (K132312)Renovis Surgical Technologies, LLC2014-04-11
INION FREEDOMPIN (K133932)Inion OY2014-04-11
PROPOSED OPTIMUS (K132596)Custom Spine, Inc.2014-04-11
STREAMLINE TL SPINAL FIXATION SYSTEM (K140696)Pioneer Surgical Technology, Inc.2014-04-10
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES (K132290)Materialise NV2014-04-10
ORTHROS POSTERIOR STABILIZATION SYSTEM (K133366)Camber Spine2014-04-08
ULTRAFUSE (K130531)Baxter Healthcare Corp2014-04-08
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 (K140069)Merete Medical GmbH2014-04-07
BAXANO SURGICAL MIS SPINAL SYSTEM (K133743)Baxano Surgical, Inc.2014-04-07
SPEED TRIAD (K133844)Biomedical Ent., Inc.2014-04-07
THREADED PEEK K-WIRE (K133235)Mtp Solutions, LLC2014-04-07
FRAGMENT PLATE SYSTEM (K140372)Skeletal Dynamics, LLC2014-04-07
ABACUS TM SPACER SYSTEM (K140007)Spine Wave, Inc.2014-04-07
TSP HIP FRACTURE PLATING SYSTEM (K140018)Biomet, Inc.2014-04-04
MEDINAUT KYPHOPLASTY SYSTEM (K133669)Imedicom2014-04-04
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW (K132911)In2bones Sas2014-04-04
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR (K133777)Tornier, Inc.2014-04-04
COROENT SMALL INTERBODY SYSTEM (K140003)Nuvasive, Inc.2014-04-03
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD (K140043)Microport Orthopedics, Inc.2014-04-03
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K133834)Depuy(Ireland)2014-04-03
ALEUTIAN IBF SYSTEM (K133614)K2m, Inc.2014-04-03
VARIAX 2 SYSTEM (K140376)Stryker Trauma AG2014-04-03
SIGNATURE PLANNER, SIGNATURE GUIDES (K140257)Materialise NV2014-04-02
INNESIS PEEK CERVICAL CAGE (K132483)Bk Meditech, Co., Ltd.2014-04-02
VARIAX CLAVICLE HOOK PLATE (K140259)Stryker Trauma AG2014-04-01
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL (K133606)ArthroCare Corporation2014-04-01
MODIFIED DISTAL RADIUS PLATING SYSTEM (K133939)Biomet2014-04-01
IMBIBE NEEDLE (K140414)Orthovita, Inc.2014-04-01
SYNTHES SYNSONIC ULNA NAIL (K131984)Synthes (Usa)2014-03-31
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 (K133721)Pinnacle Spine Group, LLC2014-03-31
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (K133940)Biomet UK, Ltd.2014-03-28
I-HIP TOTAL HIP SYSTEM (K132572)Iconacy Orthopedic Implants, LLC2014-03-28
EXTREMITY MEDICAL HAMMERTOE DEVICE (K133636)Extremity Medical, LLC2014-03-28
PEEK FUSION IMPLANT (K133515)Mtp Solutions, LLC2014-03-28
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM (K133560)Conformis, Inc.2014-03-28
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET (K133930)Flower Orthopedics Corporation2014-03-27
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K140106)Renovis Surgical Technologies, Inc.2014-03-27
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (K133455)Pioneer Surgical Technology, Inc.2014-03-27
SILEX SACROILIAC JOINT FUSION SYSTEM (K140079)X-Spine Systems, Inc.2014-03-25
VEGA KNEE SYSTEM (K140452)Aesculap Implant Systems2014-03-25
CD HORIZON SPINAL SYSTEM (K140449)Medtronic Sofamor Danek, Inc.2014-03-25
NAUTILUS SPINAL SYSTEM (K140457)Life Spine, Inc.2014-03-25
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (K132250)Integra LifeSciences Corporation2014-03-24
VARIAX DISTAL RADIUS PLATING SYSTEM (K133974)Stryker Leibinger GmbH2014-03-24
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW (K130550)Encore Medical L.P.2014-03-24
PRODENSE BONE GRAFT SUBSTITUTE (K132656)Wrightmedicaltechnologyinc2014-03-24
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM (K133944)K2m, Inc.2014-03-21
CAMBER SPINE DIAGON OBLIQUE CAGE (K134038)Camber Spine2014-03-20
CAMBER SPINE COVERIS CERVICAL CAGE (K133529)Camber Spine2014-03-20
TYBER MEDICAL TRAUMA SCREW (K133842)Tyber Medical, LLC2014-03-20
SPEED XL (K133780)Biomedical Ent., Inc.2014-03-19
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM (K133374)Pioneer Surgical Technology, Inc. (Rti Surgical, I2014-03-19
METALLIC INTRAMEDULLARY NAIL SYSTEM (K132078)Tianjin Walkman Biomaterial Co., Ltd.2014-03-19
BG MORSELS (K132805)Prosidyan, Inc.2014-03-14
STERISPINE LC CAGE (K133893)Safe Orthopaedics2014-03-14
OMNI ARC MONOBLOCK HIP STEM (K133381)Omnilife Science2014-03-13
ULTRACONGRUENT INSERT (K132752)United Orthopedic Corporation2014-03-13
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM (K133205)Medtronic Sofamor Danek USA, Inc.2014-03-13
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS (K133832)Total Joint Orthopedics, Inc.2014-03-13
ARSENAL SPINAL FIXATION SYSTEM (K133221)Alphatec Spine, Inc.2014-03-13
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