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Orthopedic

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

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RecordFirmDate
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (K082095)Smith & Nephew Endoscopy, Inc.2008-10-21
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K082375)OrthoPediatrics Corp.2008-10-17
BLACKSTONE PEDICLE SCREW SYSTEM (K082797)Blackstone Medical, Inc.2008-10-17
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD (K081348)TriMed, Inc.2008-10-17
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES (K082260)Calvary Spine, LLC2008-10-17
ACCIN TOTAL KNEE SYSTEM (K081127)Accelerated Innovation, LLC2008-10-17
SPINAL USA VBR SYSTEM (K081196)Spinal USA2008-10-16
MODIFICATION TO: CAPSTONE SPINAL SYSTEM (K082732)Medtronic Sofamor Danek USA, Inc.2008-10-16
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V (K081759)Zimmer GmbH2008-10-16
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES (K082615)Osteotech, Inc.2008-10-16
POLYBONE GRANULE & BLOCK (K082338)Kyung Won Medical Co., Ltd.2008-10-16
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS (K082398)Encore Medical L.P.2008-10-15
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS (K082446)Biomet, Inc.2008-10-15
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III (K082081)Mako Surgical Corp.2008-10-15
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (K080399)Musculoskeletal Transplant Foundation2008-10-10
ENSPLINTCMX CLAVICLE PIN (K081832)Sonoma Orthopedic Products, Inc.2008-10-10
CD HORIZON SPINAL SYSTEM (K082236)Medtronic Sofamor Danek2008-10-10
NUVASIVE SPHERX SYSTEM (K082332)Nuvasive, Inc.2008-10-10
T2 FLEXIBLE NAIL (K082018)Howmedica Osteonics Corp.2008-10-10
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY (K082702)Exactech, Inc.2008-10-10
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS (K081107)K2m, Inc.2008-10-10
STARR FRAME STEINMANN PIN (K082017)Starr Frame, LLC2008-10-10
TRICOS A RESORBABLE BONE SUBSTITUTE (K081717)Baxter Healthcare Corp2008-10-10
LDR SPINE EASYSPINE SYSTEM (K082592)Ldr Spine USA2008-10-08
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 (K082608)Stryker Spine2008-10-07
SYNERGY SPINAL SYSTEM (6.35 POLARIS) (K081952)Biomet Spine2008-10-07
MODIFICATION TO MICROFUSE BONE VOID FILLER (K082442)Globus Medical, Inc.2008-10-07
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) (K082032)Abbott Spine, Inc.2008-10-06
PASS LP SPINAL SYSTEM (K082577)Medicrea Technologies2008-10-03
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (K082567)Howmedica Osteonics Corp.2008-10-03
PASS 2 SPINAL SYSTEM (K082069)Medicrea Technologies2008-10-03
ATLAS SPINE SPACER (K081880)Atlas Spine, Inc.2008-10-02
NUVASIVE COROENT SYSTEM (K081611)Nuvasive, Inc.2008-10-02
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 (K081893)Arthrocare Corp.2008-10-01
ENCORE SHOULDER REVISION GLENOID (K081448)Encore Medical L.P.2008-09-30
SEEPLATE CERVICAL PLATE SYSTEM (K082037)Amedica Corp.2008-09-26
UNITED U2 PATELLA (K082469)United Orthopedic Corp.2008-09-26
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS (K081860)Zimmer, Inc.2008-09-26
ACCELL TBM-R (K081817)Isotis Orthobiologics, Inc.2008-09-24
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM (K081883)Us Spine2008-09-24
NUVASIVE LATERAL PLATE SYSTEM (K082070)Nuvasive, Inc.2008-09-24
4CIS SOLAR AND APOLLON SPINE SYSTEMS (K082453)Solco Biomedical Co., Ltd.2008-09-23
UNIVATION UNICONDYLAR KNEE SYSTEM (K081293)Aesculap Implant Systems, Inc.2008-09-22
NOVEL CERVICAL SPINAL SPACER SYSTEM (K081730)Alphatec Spine, Inc.2008-09-19
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS (K082516)Smith & Nephew, Inc.2008-09-17
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM (K082270)Vertiflex, Inc.2008-09-16
BLACKSTONE PEDICLE SCREW SYSTEM (K081684)Blackstone Medical, Inc.2008-09-15
MODIFICATION TO CAPSTONE SPINAL SYSTEM (K082342)Medtronic Sofamor Danek2008-09-12
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE (K082073)Apatech , Ltd.2008-09-11
LUCENT MAGNUM+ (K081711)Spinal Elements, Inc.2008-09-11
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K082273)Depuy Spine, Inc.2008-09-10
EXPEDIUM SPINE SYSTEM (K081898)Depuy Spine, Inc.2008-09-10
SURGVIEW INTEGRATED VISUALIZATION SYSTEM (K082293)Biovision Technologies, LLC2008-09-09
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (K082146)Aesculap Implant Systems, Inc.2008-09-09
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE (K081374)Wrightmedicaltechnologyinc2008-09-09
SYNTHES RIB FIXATION SYSTEM (K081623)Synthes (Usa)2008-09-08
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES (K081614)Interbody Innovations, Llp2008-09-05
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM (K081016)Smith & Nephew, Inc.2008-09-05
BLACKSTONE PILLAR XL PEEK SPACERS (K082235)Blackstone Medical, Inc.2008-09-04
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM (K080992)Aesculap Implant Systems, Inc.2008-09-04
RE-ZORB PLATING SYSTEM (K081588)Acute Innovations, LLC2008-09-03
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM (K082195)Depuy Spine, Inc.2008-09-03
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 (K081758)Depuy Spine, Inc.2008-09-03
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ (K082022)Exactech, Inc.2008-09-02
ANTEGRA-T (K081568)Synthes Spine Co.Lp2008-09-02
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM (K081622)Abbott Spine, Inc.2008-08-29
DEPUY C-STEM AMT (K082239)DePuy Orthopaedics, Inc.2008-08-29
EXTREMITY MEDICAL COMPRESSION SCREW (K081934)Extremity Medical, LLC2008-08-29
OPACITY + BONE CEMENT (K080873)Teknimed, S.A.2008-08-28
SYGNAL DBM (K080405)Musculoskeletal Transplant Foundation2008-08-28
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE (K081849)Blackstone Medical, Inc.2008-08-28
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (K082194)Laurimed, LLC2008-08-28
T2 XVBR SPINAL SYSTEM (K082112)Medtronic Sofamor Danek2008-08-27
SMALL BONE LOCKING PLATING SYSTEM (K081546)DePuy Orthopaedics, Inc.2008-08-26
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S (K081511)Smith & Nephew, Inc.2008-08-26
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC (K081558)Pioneer Surgical Technology2008-08-25
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS (K081566)Smith & Nephew, Inc.2008-08-21
JMEA CANNULATED BONE SCREW SYSTEM (K080259)Jmea Corporation2008-08-20
REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 (K081679)Encore Medical L.P.2008-08-20
REPROCESSED EXTERNAL FIXATION DEVICE (K081586)Sterilmed, Inc.2008-08-18
HIPLOC COMPRESSION HIP SCREW (K080685)Biomet Manufacturing, Inc.2008-08-15
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (K081038)Medtronic Sofamor Danek2008-08-15
REPROCESSED EXTERNAL FIXATION ACCESSORIES (K081342)Sterilmed, Inc.2008-08-13
TRAUSON BONE PLATE (K073432)Trauson (Jiangsu) Medical Instrument Co., Ltd.2008-08-13
BIOACTIF OSTEOTRANS INTERFENCE SCREW (K081390)Takiron Co., Ltd.2008-08-12
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION (K082148)Synthes (Usa)2008-08-11
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER (K080990)DePuy Orthopaedics, Inc.2008-08-08
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE (K081051)Spine View, Inc.2008-08-07
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (K073499)Zimmer, Inc.2008-08-07
METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM (K081973)Aesculap Implant Systems, Inc.2008-08-07
PEEK-OPTIMA ALIF SPACER (K081636)Biomet Spine2008-08-07
BIOPRO GO-EZ SCREW (K081149)Biopro, Inc.2008-08-05
MODIFICATION TO LUCENT (K081968)Spinal Elements, Inc.2008-08-05
TIGER CANNULATED SCREW SYSTEM (K081510)Trilliant Surgical, Ltd.2008-08-04
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING (K081876)Osteomed LP2008-08-01
MDF REVISION HIP SYSTEM (K081124)Smith & Nephew, Inc.2008-07-31
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS (K081244)Biomet Trauma2008-07-30
MAESTRO WRIST FRACTURE IMPLANT (K080426)Biomet Manufacturing Corp2008-07-29
STRYKER SPINE AVS PL PEEK SPACERS (K082014)Stryker Corp.2008-07-28
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) (K081497)Arthrocare Corp.2008-07-28
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