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Orthopedic

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

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RecordFirmDate
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM (K092493)Gpc Medical, Ltd.2010-03-29
G-FORCE TI SUTURE ANCHOR SYSTEM (K100579)Wrightmedicaltechnologyinc2010-03-26
INDUS ANTERIOR CERVICAL PLATE SYSTEM (K093776)Spinefrontier, Inc.2010-03-26
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE (K093808)Incite Innovation, LLC2010-03-24
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY (K092046)Berkeley Advanced Biomaterials, Inc.2010-03-24
OPUS SPEEDSCREW SYSTEM (K100457)Arthrocare Corp.2010-03-19
SMPLE PLATE AND SCREWS (K093983)Biomet Trauma (Aka Ebi, Lp)2010-03-19
ARTHREX TIBIAL GRAFTBOLT (K093912)Arthrex, Inc.2010-03-18
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS (K093419)Stryker Instruments, Instruments Div.2010-03-18
MODIFICATION TO: OASYS SYSTEM (K093670)Stryker Spine2010-03-18
SEC IBF CAGE (K093669)Innvotec Surgical, Inc.2010-03-18
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 (K100532)Depuy Mitek, A Johnson & Johnson Company2010-03-17
OMNITECH LARGE, TRIMED COMPRESSION SCREW (K093676)TriMed, Inc.2010-03-17
IMPIX MANTA CERVICAL INTERBODY DEVICE (K100484)Medicrea2010-03-16
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER (K092825)Spinecraft, Inc.2010-03-16
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS (K092265)Medacta International S.A.2010-03-12
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS (K092474)K2m, Inc.2010-03-11
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093936)Spineart2010-03-11
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX (K093864)Stryker Corp.2010-03-11
TC PLATING SYSTEM (K094037)Ortho-Pro, LLC2010-03-10
E1 ANTIOXIDANT INFUSED TECHNOLOGY (K100048)Biomet Manufacturing Corp2010-03-09
SYNTHES MATRIX MIS RODS (K093668)Synthes (Usa)2010-03-09
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM (K093629)Biomet Spine2010-03-09
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 (K094017)Omni Life Science, Inc.2010-03-05
CHESAPEAKE SPINAL SYSTEM (K092211)K2m, Inc.2010-03-05
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM (K093943)Smith & Nephew Inc., Endoscopy Div.2010-03-05
STRYKER ARTHROSCOPE (K093677)Stryker Endoscopy2010-03-05
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM (K093761)Biomet Trauma (Aka Ebi, Lp)2010-03-05
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR (K093897)Smith & Nephew Inc., Endoscopy Div.2010-03-04
EVOLUTION MP TOTAL KNEE SYSTEM (K093552)Wrightmedicaltechnologyinc2010-03-04
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (K093127)Zimmer Trabecular Metal Technology2010-03-04
AESCULAP HYDROLIFT VBR SYSTEM (K083186)Aesculap Implant System, Inc.2010-03-04
PASS LP SPINAL SYSTEM (K100297)Medicrea Technologies2010-03-04
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; (K092331)Encore Medical L.P.2010-03-03
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL (K090658)Synthes (Usa)2010-03-03
MEDACTA BIPOLAR HEAD (K091967)Medacta International S.A.2010-03-02
A-GRIX RESORBABLE BONE VOID FILLER (K091688)Ag Digital Technology Corp.2010-03-02
C-MOR VISUALIZATION DEVICE (K093717)Axis Surgical Technologies, Inc.2010-03-02
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 (K093463)Care Fusion2010-02-26
BINDER INTERVERTEBRAL BODY FUSION DEVICE (K093015)Binder Biomedical, Inc.2010-02-25
POWERPUMP ARTHROSCOPY SYSTEM (K093409)Medical Vision AB2010-02-24
HAMMERLOCK (K091951)Biomedical Ent., Inc.2010-02-19
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS (K100197)Smith & Nephew, Inc.2010-02-19
OSCAR 3 (K093805)Orthosonics, Ltd.2010-02-19
NUVASIVE HELIX REVOLUTION ACP SYSTEM (K093804)Nuvasive, Inc.2010-02-19
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM (K092295)Pioneer Surgical Technology2010-02-19
CARRIGEN (K093447)Etex Corp.2010-02-18
EDGELOCK (K093900)Orthohelix Surgical Designs, Inc.2010-02-17
REVERE STABILIZATION SYSTEM (K093294)Globus Medical, Inc.2010-02-17
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100138)Alphatec Spine, Inc.2010-02-17
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 (K093533)Materialise NV2010-02-17
SKELTEX ISV (K091234)Skeltex Technologies, Inc.2010-02-16
MODIFICATION TO CAPSURE PS SYSTEM (K100122)Spine Wave, Inc.2010-02-12
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX (K100061)K2m, Inc.2010-02-12
ORTHO SELECT BONE PLATES AND SCREW SYSTEM (K091493)Ortho Select Implant Technology Gesellschaft2010-02-05
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM (K093567)Anova Implant Solutions, LLC2010-02-05
CORIN METAFIX FEMORAL STEM (K082525)Corin USA2010-02-04
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K100070)Depuy Spine, Inc.2010-02-04
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY (K100044)Blackstone2010-02-04
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS (K093846)Zimmer, Inc.2010-02-04
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 (K092836)Depuy Mitek, A Johnson & Johnson Company2010-02-04
VERTOS MEDICAL MILD DEVICE KIT (K093062)X-Sten Corp.2010-02-04
ESL SPINAL SYSTEM (K092574)Ebi, L.P.2010-02-04
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM (K092531)Spine3602010-02-04
EVOLVE EPS ORTHOLOC (K100146)Wrightmedicaltechnologyinc2010-02-02
ATLAS INTERVERTEBRAL BODY CAGE (K092774)Spinal Edge, LLC2010-02-02
DEPUY FRACTURE AND FUSION PLATING SYSTEM (K093474)DePuy Orthopaedics, Inc.2010-02-02
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION (K093433)Howmedica Osteonics Corp.2010-01-28
VALEO SPACER SYSTEM (K091278)Amedica Corp.2010-01-28
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER (K092540)Rsb Spine, LLC2010-01-27
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (K093363)Smith & Nephew, Inc.2010-01-26
ANY PLUS SPINAL FIXATION SYSTEM (K091717)GS Medical Co., Ltd.2010-01-25
ACP4 SPINAL IMPLANT SYSTEM (K092360)X-Spine Systems, Inc.2010-01-22
MODIFIED: NEWDEAL HALLU PLATES (K093781)Newdeal Sas2010-01-22
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS (K092098)Smith & Nephew, Inc.2010-01-22
BIOFOAM BONE WEDGE MODEL ASSORTED (K093950)Wrightmedicaltechnologyinc2010-01-22
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II (K092124)Trans1 Incorporated2010-01-21
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S (K093944)Medacta International S.A.2010-01-21
QUANTUM M COMPOSITE NAILING SYSTEM (K091425)N.M.B. Medical Applications, Ltd.2010-01-21
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) (K092110)Sonoma Orthopedic Products, Inc.2010-01-20
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 (K092754)Small Bone Innovations, Inc.2010-01-19
BLADE ANTERIOR CERVICAL PLATE SYSTEM (K091936)Nexxt Medical, Inc.2010-01-19
LIFE SPINE LUMBAR PLATE SYSTEM (K093200)Life Spine2010-01-19
ASCENSION METAL GREAT TOE SYSTEM (K092047)Ascension Orthopedics, Inc.2010-01-14
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) (K092909)Synthes (Usa)2010-01-11
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T (K093360)Exactech, Inc.2010-01-11
ORTHOSS (K090401)Ed. Geistlich Soehne AG Fur Chemische Industrie2010-01-08
MOUNTAINEER LAMINOPLASTY SYSTEM (K091994)Depuy Spine, Inc.2010-01-07
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM (K092900)Exactech, Inc.2010-01-07
MINI RAIL EXTERNAL FIXATOR SYSTEM (K093550)Small Bone Innovations, Inc.2010-01-07
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM (K092162)Solco Biomedical Co., Ltd.2010-01-06
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) (K090986)Dfine, Inc.2009-12-30
SYNTHES MATRIX SYSTEM (K092929)Synthes (Usa)2009-12-29
AVS PL PEEK SPACERS (K093704)Stryker Corp.2009-12-23
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 (K093675)Vertebral Technologies, Inc.2009-12-23
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT (K092803)Cardo Medical Corp.2009-12-23
PATRIOT TRANSCONTINENTAL LLIF SPACER (K093242)Globus Medical, Inc.2009-12-23
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES (K091644)Synthes (Usa)2009-12-23
CERVICORE CORPECTOMY CAGE (K091426)Verticor, Ltd.2009-12-23
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K093077)Alphatec Spine, Inc.2009-12-23
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