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Orthopedic

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

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RecordFirmDate
GOLDEN GATE ANTERIOR PLATE SYSTEM (K101353)Ulrich GmbH & Co. KG2011-02-04
COHESION BONE CEMENT (K103816)Teknimed Sas2011-02-04
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE (K110045)Vertebral Technologies, Inc.2011-02-03
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS (K103309)Smith & Nephew Endoscopy, Inc.2011-02-03
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT (K103233)Howmedica Osteonics Corp.2011-02-03
POLARIS SPINAL SYSTEM (K103393)Biomet Spine2011-02-02
SIGNATURE PLANNER; SIGNATURE GUIDES (K102795)Materialise NV2011-02-02
TALON SPINAL SYSTEM (K102995)Spine3602011-02-02
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM (K102924)Tornier, Inc.2011-01-31
PICCOLO COMPOSITE NAILING SYSTEM (K102369)N.M.B. Medical Applications, Ltd.2011-01-31
SMITH & NEPHEW SMF HIP STEM (K103256)Smith & Nephew, Inc.2011-01-31
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM (K103208)Encore Medical L.P.2011-01-31
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, (K101263)Lima-Lto S.P.A.2011-01-28
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 (K101459)Smith & Nephew, Inc.2011-01-27
REDONDO-L (K103297)Seaspine, Inc.2011-01-27
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY (K102722)Synthes USA Products, LLC2011-01-27
CD HORIZON SPINAL SYSTEM (K102886)Medtronic Sofamor Danek, Inc.2011-01-26
CONSENSUS KNEE SYSTEM (K102927)Consensus Orthopedics, Inc.2011-01-26
ORTHOVITA PEEK SPACER (K101171)Orthovita, Inc.2011-01-25
FLAMENCO SPINAL FIXATION SYSTEM (K102853)Ulrich GmbH & Co. KG2011-01-25
KYPHON INFLATION SYRINGE (K103231)Medtronic Spine, LLC2011-01-24
TOTAL SHOULDER SYSTEM (K102670)Shoulder Innovations, LLC2011-01-24
APTUS ULNA PLATES (K103332)Medartis AG2011-01-24
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (K103243)Synthes (Usa)2011-01-21
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM (K102870)Exactech, Inc.2011-01-21
TAPERLOC COMPLETE, SIZE 5 AND 6 (K103755)Biomet Manufacturing Corp2011-01-21
EMERALD SPINAL SYSTEM (K101446)Mazor Surgical Technologies , Ltd.2011-01-20
R3 XLPE ANTEVERTED LINERS (K102370)Smith & Nephew, Inc.2011-01-19
SP-FIX SPINOUS PROCESS FIXATION PLATE (K102195)Globus Medical, Inc.2011-01-19
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM (K103533)Advanced Orthopaedic Solutions, Inc.2011-01-19
VEPER SYSTEM, EXPEDIUM SYSTEM (K103133)Depuy Spine, Inc.2011-01-18
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE (K083894)4-Web Spine, LLC2011-01-18
E1 AVANTAGE HEAD (K101336)Biomet Manufacturing Corp2011-01-14
ORTHOFLEX ROD (K102601)Ortho-Pro, LLC2011-01-14
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX (K102885)Stryker Corp.2011-01-14
KING COBRA ANTERIOR CERVICAL PLATE (K103068)Eminent Spine2011-01-14
CASPIAN SPINAL SYSTEM (K103232)K2m, Inc.2011-01-13
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR (K102121)Apollo Spine, Inc.2011-01-12
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + (K103070)G Surgical Co., Ltd.2011-01-12
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) (K102834)Kinamed, Incorporated2011-01-12
AVAMAX VERTEBRAL BALLOON (K103064)Care Fusion2011-01-10
ALLOFUSE PLUS (K103036)Allosource, Inc.2011-01-10
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX (K103033)Zimmer Trabecular Metal Technology2011-01-10
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) (K102322)Omni Surgical, L.P.2011-01-07
ARTHREX SWIVELOCK ANCHORS (K101823)Arthrex, Inc.2011-01-07
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K103117)Conformis, Inc.2011-01-07
EVOLUTION MP TOTAL KNEE SYSTEM (K102380)Wrightmedicaltechnologyinc2011-01-07
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND (K102298)Depuy Mitek, A Johnson & Johnson Company2011-01-07
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL (K101588)Apollo Spine, Inc.2011-01-07
THE GRAPPLR AND GRAPPLR EXTENDER (K101616)Tag Medical Corp.2011-01-06
PARAMOUNT R IBF DEVICE (K103228)Theken Spine, LLC2011-01-05
ENDOBUTTON DIRECT (K102982)Smith & Nephew Inc., Endoscopy Division2011-01-05
SYNTHES 6.0 COCR AND CPT TI-3 RODS (K103287)Synthes Spine2011-01-05
CALIBER SPACER (K102293)Globus Medical, Inc.2011-01-05
ARTHREX TIBIAL GRAFTBOLT (K103060)Arthrex, Inc.2011-01-05
MULTIFIT TOTAL HIP SYSTEM (K101472)Otis Biotech Co., Ltd.2011-01-05
CONGRUENT BONE PLATE SYSTEM (K102998)Acumed, LLC2011-01-04
F20 (K103433)Teknimed, S.A.2011-01-03
ZENIUS SPINAL SYSTEM (K103272)Medyssey Co, Ltd.2010-12-29
ACL TIGHTROPE DOUBLE BUNDLE (K101837)Arthrex, Inc.2010-12-28
OSTEOPHIL BETA-TCP (K102937)Cytophil, Inc.2010-12-27
TSRH SPINAL SYSTEM (K103049)Medtronic Sofamor Danek2010-12-23
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES (K102992)Howmedica Osteonics Corp.2010-12-22
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS (K102565)Wrightmedicaltechnologyinc2010-12-22
MICROFUSE PUTTY AND MICROFUSE ST MIS (K102392)Globus Medical, Inc.2010-12-22
ARTHREX UNIVERS II SHOULDER PROSTHESIS (K103466)Arthrex, Inc.2010-12-22
TARGON FN SYSTEM (K102057)Aesculap Implant Systems, LLC2010-12-21
MATRYX INTERFERENCE SCREW (5.0-6.5MM) (K102410)Conmed Linvatec2010-12-21
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (K103223)Encore Medical L.P.2010-12-21
ENDURO KNEE SYSTEM (K101815)Aesculap Implant Systems2010-12-20
TWISTCUT ENDOSORB SCREWS (K102777)Merete Medical GmbH2010-12-20
SYNTHES ZERO-P (K093762)Synthes Spine2010-12-20
INERTIA PEDICLE SCREW SYSTEM (K101278)Nexxt Spine, LLC2010-12-20
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK (K103189)Medacta International S.A.2010-12-20
RHEAD RADIAL HEAD EXTENDED STEMS (K102180)Small Bone Innovations, Inc.2010-12-20
EXPEDIUM SPINE SYSTEM (K102249)Depuy Spine, A Johnson & Johnson Company2010-12-16
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (K103147)Medyssey Co, Ltd.2010-12-16
POSTERIOR LATERAL PLATES (K103408)DePuy Orthopaedics, Inc.2010-12-16
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE (K102323)Theken Spine, LLC2010-12-16
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE (K101363)Musculoskeletal Clinical Regulatory Advisers2010-12-16
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K101996)Depuy(Ireland)2010-12-15
CONTOURS LAPIDUS PLATING SYSTEM (K102201)Orthofix, Inc.2010-12-15
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 (K103374)Wrightmedicaltechnologyinc2010-12-14
SIMMETRY SACROILIAC JOINT FUSION SYSTEM (K102907)Zyga Technology, Inc.2010-12-14
TRABECULAR METAL TIBIAL CONE AUGMENTS (K102896)Zimmer Trabecular Metal Technology2010-12-13
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS (K102660)Smith & Nephew Endoscopy, Inc.2010-12-13
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM (K103419)Exactech, Inc.2010-12-13
APEX SPINE SYSTEM W/ COCR RODS (K102488)Spinecraft, LLC2010-12-10
DEPUY ATTUNE KNEE SYSTEM (K101433)DePuy Orthopaedics, Inc.2010-12-10
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, (K100858)Lima-Lto S.P.A.2010-12-10
GENESYS SPINE INTERBODY FUSION SYSTEM (K103034)Genesys Spine2010-12-10
APTUS 1.5 TRILOCK (K102537)Medartis AG2010-12-10
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES (K102694)Synthes (Usa)2010-12-09
SELF RETAINING SOFT TISSUE RETRACTOR (K101609)Koros USA, Inc.2010-12-09
PREVISION HIP SYSTEM WITH RECON RING (K102424)Aesculap Implant Systems, LLC2010-12-09
OPTIGEN TOTAL KNEE SYSTEM (K102367)U&I Corp.2010-12-08
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM (K102143)Suspension Orthopaedic Solutions, LLC2010-12-08
S 100 PEDICLE SCREW SYSTEM (K101682)Renovis Surgical Technologies, LLC2010-12-07
ARCOS INTERLOCKING DISTAL STEMS (K100469)Biomet Manufacturing Corp2010-12-07
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES (K102282)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2010-12-07
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