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Orthopedic

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

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RecordFirmDate
BEACON STABILIZATION SYSTEM (K121922)Globus Medical, Inc.2012-07-26
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS (K121183)Biomet Corporation2012-07-26
PIONEER STERNAL ASSIST IMPLANT SYSTEM (K120016)Pioneer Surgical Technology, Inc.2012-07-26
STRYKER ALL SUTURE ANCHORS (K120509)Stryker2012-07-26
LDR SPINE USA AVENUE L INTERBODY FUSION (K113285)Ldr Spine USA, Inc.2012-07-26
SOVEREIGN SPINAL SYSTEM (K121982)Medtronic Sofamor Danek2012-07-26
HLS UNI EVOLUTION & U-KNEETEC (K120262)Tornier, Inc.2012-07-25
SYNTHES ZERO-P VARIABLE ANGLE (VA) (K121852)Synthes Spine Co.Lp2012-07-25
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K121252)Stryker Corp.2012-07-25
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) (K121658)Orthofix, Inc.2012-07-20
GMK SPHERE (K121416)Medacta International2012-07-20
SURGICASE CONNECT, SURGICASE GUIDE (K112389)Materialise NV2012-07-20
CASIAN, 3.5/4.5 CONNECTORS (K121808)K2m, Inc.2012-07-20
DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE (K121835)Encore Medical L.P.2012-07-20
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING (K120211)Smith & Nephew, Inc.2012-07-19
U2 ACETABULAR CUP, PLASMA SPRAY (K121777)United Orthopedic Corp.2012-07-18
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER (K121349)Extremity Medical, LLC2012-07-18
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM (K121671)Zimmer Spine, Inc.2012-07-18
M.U.S.T PEDICLE SCREW SYSTEM (K121115)Medacta International2012-07-18
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM (K121417)Extremity Medical, LLC2012-07-18
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE (K121323)Medicrea International2012-07-18
3.9MM REELX STT SUTURE ANCHOR SYSTEM (K120824)Stryker Corp.2012-07-18
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM (K121837)Nuvasive, Inc.2012-07-16
CALYPSO SYSTEM (K120564)Hogan Lovells US LLP2012-07-16
INFILL INTERVERTEBRAL BODY FUSION DEVICE (K121733)Pinnacle Spine Group, LLC2012-07-13
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE (K120903)Acumed, LLC2012-07-13
ARROW REVERSE SHOULDER SYSTEM (K112193)Fournitures Hospitalieres Industrie2012-07-12
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM (K112748)Spinal USA, LLC2012-07-11
SEVIIN REVERSE SHOULDER (K120374)Ingen Orthopedics, LLC2012-07-09
SYNTHES MULTILOC HUMERAL NAILING SYSTEM (K120807)Synthes USA Products, LLC2012-07-06
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K121096)L&K BIOMED Co., Ltd.2012-07-06
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE (K121601)Synthes USA2012-07-06
ACCULIF TL CAGE (K121683)Coalign Innovations, Inc.2012-07-05
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM (K120739)Tornier, Inc.2012-07-05
CD HORIZON SPINAL SYSTEM (K121680)Medtronic Sofamor Danek USA, Inc.2012-07-05
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) (K121107)Globus Medical, Inc.2012-07-03
SPINAL ELEMENTS CERCLAGE SYSTEM (K120177)Spinal Elements, Inc.2012-07-03
SPINE FRONTIER INDUS ACP SYSTEM (K121060)Spinefrontier, Inc.2012-07-03
DEPUY PULSE LUMBAR CAGE SYSTEM (K120966)Medos International SARL2012-07-03
WAVE O CAGE (K121330)Advanced Medical Technologies AG2012-06-29
FUSE CAGE (K121288)Advanced Medical Technologies AG2012-06-29
VERTEX RCCONSTRUCTION SYSTEM (K121191)Medtronic Sofamor Danek, Inc.2012-06-29
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL (K120990)Zimmer Trabecular Metal Technology2012-06-29
FREEDOM(R) STEMMED TIBIAL COMPONENTS (K111785)Maxx Orthopedics, Inc.2012-06-29
LOOP CAGE (K121332)Advanced Medical Technologies AG2012-06-29
WAVE D CAGE (K121333)Advanced Medical Technologies AG2012-06-29
NUVASIVE COROENT TITANIUM SYSTEM (K120918)Nuvasive, Inc.2012-06-28
RANGE SPINAL SYSTEM (MESA AND DENALI) (K121016)K2m, Inc.2012-06-27
LDR SPINE SPINETUNE TL SPINAL SYSTEM (K120760)Ldr Spine USA, Inc.2012-06-27
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K121049)Globus Medical, Inc.2012-06-27
VU APOD INTERVERTEBRAL BODY FUSION DEVICE (K121211)Theken Spine, LLC2012-06-27
ENSPIRE DISCECTOMY SYSTEM (K120680)Spine View, Inc.2012-06-26
XTRAFIX EXTERNAL FIXATION SYSTEM (K113383)Extraortho, Inc.2012-06-26
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN (K121018)Smith & Nephew, Inc.2012-06-22
XIA 4.5 SPINAL SYSTEM (K121342)Stryker Corp.2012-06-22
ASCEND SHOULDER SYSTEM (K121493)Tornier, Inc.2012-06-20
BLUE MOUNTAIN CERVICAL PLATE (K112809)Qualgenix, LLC2012-06-20
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (K112030)Synthes USA, LLC2012-06-19
OP SPINE SYSTEM (K121250)OrthoPediatrics Corp.2012-06-19
LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; (K121024)Encore Medical L.P.2012-06-19
SYNTHES VA LCP ANKLE TRAUMA SYSTEM (K120854)Synthes USA2012-06-18
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (K121130)Biomet Spine2012-06-15
MEDYSSY LT CAGE SYSTEM (K121246)Medyssey Co, Ltd.2012-06-15
TM-400 DEVICE (K120203)Zimmer Trabecular Metal Technology, Inc.2012-06-15
SIGNATURE PLANNER,SIGNATURE GUIDES (K111863)Materialise NV2012-06-15
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136)Depuy Spine, Inc.2012-06-14
REVERE 4.5 STABILIZATION SYSTEM (K113395)Globus Medical, Inc.2012-06-14
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE (K121129)Spineology, Inc.2012-06-13
HONOUR SPACER SYSTEM (K120345)Nexxt Spine, LLC2012-06-13
MINI MAXLOCK EXTREME PLATING SYSTEM (K121437)Orthohelix Surgical Designs, Inc.2012-06-13
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS (K112897)Renovis Surgical Technologies, LLC2012-06-13
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE (K120772)Zimmer GmbH2012-06-12
DEPUT DELTA XTEND REVERSE SHOULDER (K120174)Depuy France2012-06-11
GMK - LINE EXTENSION (K120790)Medacta International2012-06-08
AMISTEM AND QUADRA - LINE EXTENSION (K121011)Medacta International2012-06-08
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... (K112607)Spinevision S.A.2012-06-07
CAPSURE(R) PS SYSTEM (K120646)Spine Wave, Inc.2012-06-07
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR (K120841)Kfx Medical2012-06-07
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION (K120871)Smith & Nephew, Inc.2012-06-07
CITIEFFE-TITANIUM CANNULATED SCREW (K113388)Citieffe2012-06-05
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS (K120370)Zimmer, Inc.2012-06-04
TRILLIANT SURGICAL K-WIRES (K121008)Trilliant Surgical, Ltd.2012-06-04
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM (K120689)Synthes (USA) Products, LLC2012-06-04
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS (K112900)Lima Corporate S.P.A.2012-06-01
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ (K121307)Exactech, Inc.2012-05-31
STAINLESS STEEL SPINAL SYSTEM (K120829)Theken Spine, LLC2012-05-30
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS (K120360)Ortho Solutions Limited2012-05-29
SI-FIX SACROILIAC JOINT FUSION SYSTEM (K110472)Medtronic Sofamor Danek2012-05-29
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION (K113561)Zimmer Trabecular Metal Technology2012-05-29
SYNTHES ACIS/VERTEBRAL SPACER CR (K120275)Synthes (Usa), LLC2012-05-25
I-FUSE HAMMER TOE SYSTEMS (K113006)Orthopro, LLC2012-05-25
RANGE SPINAL SYSTEM, UNIT ROD (K120899)K2m, Inc.2012-05-25
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K112905)Biomet Orthopedics, LLC2012-05-24
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120840)L&K BIOMED Co., Ltd.2012-05-24
LEXUS CERVICAL FIXATION SYSTEM (K120879)L&K BIOMED Co., Ltd.2012-05-23
TEMPUS CERVICAL PLATE SYSTEM (K120515)Neurostructures, LLC2012-05-23
LUCENT OR LUCENT MAGNUM (K110632)Spinal Elements, Inc.2012-05-23
TAPER SET HIP SYSTEM RDP STEM (K121263)Consensus Orthopedics, Inc.2012-05-22
DYNA LOCKING ANKLE NAIL (K120419)U&I Corp.2012-05-21
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271)Biomet Manufacturing, Inc.2012-05-18
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