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Orthopedic

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

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RecordFirmDate
BLACKSTONE SFS PARALLEL ROD CONNECTORS (K080407)Blackstone Medical, Inc.2008-03-13
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE (K080352)Depuy Mitek, A Johnson & Johnson Company2008-03-12
GRAFTYS BCP (K073064)Graftys2008-03-11
KIMBA MINI (K080349)Signus Medizintechnik GmbH2008-03-10
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K080258)Endius, Inc.2008-03-10
MERRIES K-PHATE BONE GRAFT SUBSTITUTE (K063157)Merries International, Inc.2008-03-10
ZIMMER POROLOCK MIS STEM (K071723)Zimmer GmbH2008-03-07
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K073286)Zimmer, Inc.2008-03-07
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE (K072212)Smith & Nephew, Inc.2008-03-07
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX (K073470)Stryker Spine2008-03-06
TWINFIX PK FP SUTURE ANCHOR (K073509)Smith & Nephew, Inc.2008-03-04
PLEXUR M (K073405)Osteotech, Inc.2008-03-03
5.5 MM SUTURE LOCK BONE SCREW ANCHOR (K080229)Kfx Medical2008-02-29
ACCIN PATELLOFEMORAL SYSTEM (K073120)Accelerated Innovation, LLC2008-02-29
DC ULNAR SHORTENING SYSTEM (K073228)Orthopro, LLC2008-02-29
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM (K073402)Synthes (Usa)2008-02-29
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW (K073688)Exactech, Inc.2008-02-29
SYGNAL DBM (K073329)Musculoskeletal Transplant Foundation2008-02-28
APEX-LNK POLY ACETABULAR CUP LINERS (K073150)Omni Life Science, Inc.2008-02-27
CHARLOTTE CLAW 3.5 (K080295)Wrightmedicaltechnologyinc2008-02-27
ENSPLINTRX BONE FIXATION SYSTEM (K071809)Sonoma Orthopedic Products, Inc.2008-02-21
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K073460)Synthes (Usa)2008-02-21
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM (K073065)Osteomed LP2008-02-21
DEPUY TRI-LOCK BONE PRESERVATION STEM (K073570)DePuy Orthopaedics, Inc.2008-02-21
NEWDEAL TIBIAXYS SYSTEM (K073375)Newdeal Sas2008-02-21
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX (K073232)Spinefrontier, Inc.2008-02-20
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM (K073426)Cayenne Medical, Inc.2008-02-19
UNICOMPARTMENTAL KNEE (K072704)Valpo Orthopedic Technology, Inc.2008-02-19
DVO EXTENDED ARTICULATION HUMERAL HEADS (K073331)Dvo Extremity Solutions, LLC2008-02-19
ORTHOPEDIATRICS PLATING SYSTEM (K073344)Orthopediatrics, LLC2008-02-19
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM (K073245)Vertiflex, Inc.2008-02-15
HOFFMANN LIGHT SYSTEM (K073076)Howmedica Osteonics Corp.2008-02-15
BLACKSTONE ASCENT MULTIAXIAL SCREWS (K073420)Blackstone Medical, Inc.2008-02-14
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K080143)Stryker Spine2008-02-14
FACTS HAND AND PINCH GRIP COMBO (K073154)Global Services Group, LLC2008-02-14
VARIAX ELBOW SYSTEM (K073527)Howmedica Osteonics Corp.2008-02-14
MODIFICATION TO: APEX KNEE SYSTEM (K073602)Omnlife Science2008-02-14
MECTACER BIOLOX FORTE-FEMORAL HEADS (K073337)Medacta International S.A.2008-02-13
ORIA NATURA SPACER (K073669)Choicespine, LP2008-02-13
RELIANCE BUTTRESS WASHER SYSTEM (K073349)Reliance Medical Systems, LLC2008-02-13
ARTHREX COMPRESSION STAPLE (K080111)Arthrex, Inc.2008-02-13
THOR ANTERIOR PLATING SYSTEM (K073437)Stryker Spine2008-02-13
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM (K073510)Endius, Inc.2008-02-11
SYNTHES ZERO-P (K072981)Synthes Spine Co.Lp2008-02-11
DYNESYS TOP-LOADING SPINAL SYSTEM (K073347)Zimmer Spine, Inc.2008-02-08
CIMPLICITY SPINAL SYSTEM (K073320)Spine Smith Partners L.P.2008-02-07
SIDEKICK RAIL FIXATOR (K080071)Wrightmedicaltechnologyinc2008-02-07
SANATMETAL NAILS AND PINS (K070761)Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.2008-02-07
DYNASTY CERAMIC FEMORAL HEAD (K072656)Wrightmedicaltechnologyinc2008-02-06
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT (K072857)Medacta International S.A.2008-02-04
ACCIN PEDICLE SCREW SYSTEM (K073531)Accelerated Innovation, LLC2008-02-04
BONALIVE GRANULES (K071199)Vivoxid , Ltd.2008-02-01
ACCIN ANTERIOR CERVICAL PLATE SYSTEM (K073530)Accelerated Innovation, LLC2008-01-31
DEPUY ASR 300 ACETABULAR CUP SYSTEM (K073413)DePuy Orthopaedics, Inc.2008-01-30
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K073267)Endius, Inc.2008-01-30
ARDIS SPACER (K073202)Abbott Spine, Inc.2008-01-30
VALEO PEDICLE SCREW SPINAL SYSTEM (K073430)Amedica Corp.2008-01-29
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP (K073676)DePuy Orthopaedics, Inc.2008-01-29
NUVASIVE HELIX MINI ACP SYSTEM (K073275)Nuvasive, Inc.2008-01-29
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (K073135)Synthes (Usa)2008-01-29
BUTREX BUTTRESS PLATING SYSTEM (K072943)X-Spine Systems, Inc.2008-01-28
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (K073233)Advanced Bio-Surfaces, Inc.2008-01-28
QUANTUM-MIS CANNULATED SYSTEM (K080026)Pioneer Surgical Technology2008-01-28
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K080075)Elite Surgical Supplies (Pty), Ltd.2008-01-28
BENGAL STACKABLE CAGE SYSTEM (K073649)Depuy Spine, Inc.2008-01-25
STALIF (TM) C (K072415)Surgicraft , Ltd.2008-01-25
BIOSET XCH (K072238)Regeneration Technologies, Inc.2008-01-25
LANX INTERVERTEBRAL BODY FUSION DEVICE (K073144)Lanx, LLC2008-01-24
DEPUY SIGMA PS FEMORAL COMPONENTS (K073529)DePuy Orthopaedics, Inc.2008-01-24
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 (K080024)K2m, Inc.2008-01-24
DSS (K072969)Paradigm Spine, LLC2008-01-24
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR (K073654)Blackstone Medical, Inc.2008-01-24
CRYSTAL (K073351)Spinal Elements, Inc.2008-01-24
PATRIOT SPACERS (K072970)Globus Medical, Inc.2008-01-18
PATRIOT SPACERS: COLONIAL ACDF (K072991)Globus Medical, Inc.2008-01-18
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT (K071456)Arthrex, Inc.2008-01-17
GRYPHON BR AND HEALIX BR ANCHORS (K073412)Depuy Mitek, A Johnson & Johnson Company2008-01-17
INNERVUE DIAGNOSTIC SCOPE SYSTEM (K072879)Biomet Orthopedics, Inc.2008-01-14
TRANS1 AXIAL FIXATON SYSTEM (K073514)Trans1 Incorporated2008-01-11
SYNTHES OC FUSION AND SYNAPSE SYSTEMS (K072434)Synthes Spine Co.Lp2008-01-10
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) (K072888)Encore Medical L.P.2008-01-10
SMITH & NEPHEW MIS HIP STEM (K072417)Smith & Nephew, Inc.2008-01-10
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM (K072703)Pioneer Surgical Technology2008-01-10
ACCIN HIP SYSTEM (K073068)Accelerated Innovation, LLC2008-01-10
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (K072432)Hand Biomechanics Lab, Inc.2008-01-09
MODIFICATION TO VALEO VBR (K073505)Amedica Corp.2008-01-09
PROGENIX DMB PUTTY (K072265)Medtronic Sofamor Danek2008-01-09
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM (K073479)Life Spine2008-01-09
DEPUY PINNACLE ALTRX ACETABULAR LINERS (K072963)DePuy Orthopaedics, Inc.2008-01-09
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR (K072367)Wrightmedicaltechnologyinc2008-01-09
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES (K073481)Conmed Linvatec2008-01-07
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (K072121)Zimmer, Inc.2008-01-07
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE (K072575)Stryker Orthopaedics2008-01-07
BIOFOAM BONE WEDGE (K073535)Wrightmedicaltechnologyinc2008-01-07
LIFE SPINE CROSS CONNECTOR (K073480)Life Spine2008-01-04
NATURAL BRIDGE LP TRANSVERSE CONNECTORS (K072914)K2m, Inc.2008-01-03
H-LINK INTEGRATED ROD (K073517)Globus Medical, Inc.2008-01-03
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K071905)Lanx, LLC2007-12-28
LUCENT MAGNUM (K073348)Spinal Elements, Inc.2007-12-26
THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) (K072231)Esm Technologies, LLC2007-12-26
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