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Orthopedic

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

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RecordFirmDate
EXTREMITY MEDICAL SUTURE ANCHOR (K083151)Extremity Medical, LLC2009-01-22
MERCURY SPINAL SYSTEM (K082353)Spinal Elements, Inc.2009-01-22
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K082728)Medtronic Sofamor Danek USA, Inc.2009-01-16
BIOLOX DELTA OPTION CERAMIC HEADS (K082996)Biomet, Inc.2009-01-15
G-FORCE TENODESIS SCREW (K083150)Wrightmedicaltechnologyinc2009-01-15
MODIFICATION TO: METHA HIP SYSTEM (K083495)Aesculap Implant Systems, Inc.2009-01-15
TRAUSON GENERAL SPINAL SYSTEM (GSS) (K082617)Trauson (Jiangsu) Medical Instrument Co., Ltd.2009-01-15
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM (K083025)Synthes (Usa)2009-01-14
EXPANDABLE PEEK-OPTIMA IMPLANT (K082406)Ebi, L.P.2009-01-14
CAPSURE PS SYSTEM (K083743)Spine Wave, Inc.2009-01-13
PHENIX CERVICAL INTERBODY DEVICE (K083167)Spinal Devices, LLC2009-01-13
NEWPORT SPINAL SYSTEM (K083089)Seaspine, Inc.2009-01-13
TRAUSON INTRAMEDULLARY NAIL (K081230)Trauson (Jiangsu) Medical Instrument Co., Ltd.2009-01-13
ASCENSION SILICONE PIP (K082231)Ascension Orthopedics, Inc.2009-01-12
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES (K083240)Arthrocare Corp.2009-01-12
REVOLVE STABILIZATION SYSTEM (K083416)Globus Medical, Inc.2009-01-09
XYCOR SPINAL IMPLANT (K082466)Vertebration,Inc2009-01-09
PERI-LOC BONE PLATING AND SCREW SYSTEM (K083032)Smith & Nephew, Inc.2009-01-07
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM (K082712)Theken Spine, LLC2009-01-02
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K083213)Synthes (Usa)2008-12-30
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART (K082999)Arthrex, Inc.2008-12-30
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS (K082792)Medacta International S.A.2008-12-29
CLYDESDALE SPINAL SYSTEM (K083026)Medtronic Sofamor Danek2008-12-29
REJUVENATE MONOLITHIC HIP SYSTEM (K082892)Howmedica Osteonics Corp.2008-12-29
MODIFICATION TO:MICROFUSE BONE VOID FILLER (K083232)Globus Medical, Inc.2008-12-24
PHANTOM PLUS CAGE SYSTEM (K082801)Us Spine2008-12-22
ZUMA, MODEL 55-XXXX/56-XXXX (K082926)Seaspine, Inc.2008-12-22
RIMCLOSE BONE ANCHOR (K082729)Anulex Technologies, Inc.2008-12-19
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) (K081608)Toby Orthopaedics, LLC2008-12-19
DEPUY GLOBAL AP CTA HUMERAL HEAD (K082715)DePuy Orthopaedics, Inc.2008-12-18
MODIFICATION TO T2 RECON NAIL SYSTEM (K083437)Howmedica Osteonics Corp.2008-12-18
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS (K082527)Zimmer, Inc.2008-12-18
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES (K082625)Synthes (Usa)2008-12-17
NOVATION 12/14 CEMENTED FEMORAL STEMS (K083392)Exactech, Inc.2008-12-17
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM (K081165)Spineart2008-12-17
TOGGLELOC SYSTEM (K083070)Biomet Sports Medicine2008-12-16
UNITED U2 TOTAL KNEE SYSTEM (K082424)United Orthopedic Corp.2008-12-16
EOS SPINAL SYSTEM (K082509)Korea Bone Bank Co., Ltd.2008-12-15
VISIONSENSE STEREOSCOPIC VISION SYSTEM (K082355)Visionsense, Ltd.2008-12-15
BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (K082705)Biopro, Inc.2008-12-15
CONSERVE PRESSFIT FEMORAL COMPONENT (K082673)Wrightmedicaltechnologyinc2008-12-12
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 (K083364)DePuy Orthopaedics, Inc.2008-12-11
CLAMPFIX (K082914)Synthes Spine2008-12-11
CAPSURE(R) PS SYSTEM (K083353)Spine Wave, Inc.2008-12-11
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL (K082770)Zimmer, Inc.2008-12-11
MESA AND RANGE SPINAL SYSTEMS (K082769)K2m, Inc.2008-12-11
PASS LP SPINAL SYSTEM (K083308)Medicrea Technologies2008-12-10
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K082672)Novabone Products, LLC2008-12-09
HAV-LOK BUNION CORRECTION SYSTEM (K082384)Instratek, Inc.2008-12-08
MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574)Orthohelix Surgical Designs, Inc.2008-12-08
ALLOFUSE GEL AND PUTTY (K071849)Allosource, Inc.2008-12-04
DEPUY ASPHERE M-SPEC HEAD (K082585)DePuy Orthopaedics, Inc.2008-12-04
MICROWARE BONE PLATES AND BONE SCREWS (K072562)Microware Precision Co., Ltd.2008-12-04
MERCURY SPINAL SYSTEM (K083230)Spinal Elements, Inc.2008-12-03
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM (K082172)Mako Surgical Corporation2008-11-28
DDS STABILIZATION SYSTEM (K080241)Paradigm Spine, LLC2008-11-28
SI JOINT FUSION SYSTEM (K080398)SI-BONE, Inc.2008-11-26
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE (K082844)Encore Medical L.P.2008-11-25
ORTHOPEDIATRICS BONE SCREWS (K082949)OrthoPediatrics Corp.2008-11-25
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES (K082575)Apatech , Ltd.2008-11-25
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY (K082358)Smith & Nephew, Inc.2008-11-25
POGO SCREW (K080649)Fxdevices2008-11-25
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS (K082807)Synthes (Usa)2008-11-24
USS ILIOSACRAL, USS POLYAXIAL (K082572)Synthes Spine2008-11-24
PROGENIX PLUS (K082002)Medtronic Sofamor Danek2008-11-24
ISOELASTICU (K081025)Remi Sciences, Inc.2008-11-21
TSRH SPINAL SYSTEM (K081080)Medtronic Sofamor Danek2008-11-21
BIOLOX DELTA CERAMIC FEMORAL HEAD (K082991)Aesculap Implant Systems, Inc.2008-11-20
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS (K081380)K2m, Inc.2008-11-19
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL (K082650)Synthes (Usa)2008-11-18
DEPUY SIGMA CR-F FEMORAL COMPONENT (K082500)DePuy Orthopaedics, Inc.2008-11-18
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K081906)Globus Medical, Inc.2008-11-14
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE (K081673)Ionics Medical Corp.2008-11-14
VERTEX RECONSTRUCTION SYSTEM (K083071)Medtronic Sofamor Danek2008-11-14
DEPUY SPINE LATERAL CAGE SYSTEM (K082128)Depuy Spine2008-11-14
GENEX (K082381)Biocomposites, Ltd.2008-11-14
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM (K083028)Nuvasive, Inc.2008-11-13
BIOMET ANTERIOR LUMBAR PLATE (K082187)Ebi, L.P.2008-11-13
HOLLYWOOD, PACIFICA, REDONDO, VENTURA (K082310)Seaspine, Inc.2008-11-10
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES (K082624)Synthes (Usa)2008-11-10
SYNTHES (USA) 3.5MM LCP HOOK PLATE (K082072)Synthes (Usa)2008-11-07
HEALIX TI ANCHOR (K082282)Depuy Mitek, A Johnson & Johnson Co.2008-11-07
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (K081011)Arex USA2008-11-07
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE (K083033)Orthovita, Inc.2008-11-06
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE (K081979)Apatech , Ltd.2008-11-06
INDEPENDENCE SPACER (K082252)Globus Medical, Inc.2008-11-05
MODIFICATION TO 4CIS VANE SPINE SYSTEM (K081145)Solco Biomedical Co., Ltd.2008-11-05
DARCO SMALL SCREW (K082320)Wrightmedicaltechnologyinc2008-11-05
OSTEORAPTOR SUTURE ANCHOR (K082215)Smith & Nephew Inc., Endoscopy Division2008-11-03
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES (K082078)Zimmer, Inc.2008-11-03
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM (K082821)Spine Smith Partners L.P.2008-10-31
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT (K080979)Biomet Manufacturing Corp2008-10-31
MODFICATION TO: EXPEDIUM SPINE SYSTEM (K082942)Depuy Spine, Inc.2008-10-31
UNITY BETA ANCHOR SYSTEM (K082906)Bonutti Research, Inc.2008-10-30
DISTAL RADIO-ULNAR JOINT IMPLANT (K082839)Aptis Medical, LLC2008-10-24
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K082120)Tornier2008-10-24
VANGUARD CR STEM HOUSINGS (K082826)Biomet Manufacturing Corp2008-10-24
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (K082088)Mako Surgical Corp.2008-10-22
EVOLIS TOTAL KNEE SYSTEM (K081023)Medacta International S.A.2008-10-22
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K082774)Lanx, LLC2008-10-21
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