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Orthopedic

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

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RecordFirmDate
EXCIA TOTAL HIP SYSTEM WITH U-CAP (K060437)Aesculap, Inc.2006-03-22
AFT ALLOGRAFT FILLER TUBE (K060161)Musculoskeletal Transplant Foundation2006-03-21
NORIAN SRS BONE VOID FILLER (K060408)Synthes (Usa)2006-03-21
NORIAN SRS FAST SET PUTTY (K060406)Synthes (Usa)2006-03-20
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM (K060156)I.T.S. Implantat-Technologie-Systeme GmbH2006-03-20
STRYKER PLATING SYSTEM (K060514)Howmedica Osteonics Corp.2006-03-17
SPINE-FIX BIOMIMETIC BONE CEMENT (K043593)Teknimed, S.A.2006-03-17
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS (K053587)Ortho Development Corp.2006-03-17
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS (K053536)Zimmer GmbH2006-03-16
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS (K060127)Arthrosurface, Inc.2006-03-16
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS (K060360)Howmedica Osteonics Corp.2006-03-15
QUANTUM ANTERIOR CERVICAL PLATE SYSTEM (K060491)Quantum Orthopedics, Inc.2006-03-13
INION HEXALON BIODEGRADABLE ACL/PCL SCREW (K060393)Inion , Ltd.2006-03-13
EBI VERTEBROPLASTY SYSTEMS (K060148)Ebi, L.P.2006-03-13
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X (K060513)Sintea Biotech, Inc.2006-03-10
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488)Conformis, Inc.2006-03-09
GSS PEDICLE SCREW SYSTEM (K053573)GS Medical Co., Ltd.2006-03-08
COLLOSS E BONE VOID FILLER (K051047)Ossacur AG2006-03-08
CSS CANNULATED SCREW SYSTEM (K060428)Orthohelix Surgical Designs, Inc.2006-03-07
ALLOMATRIX CUSTOM (K053319)Wrightmedicaltechnologyinc2006-03-06
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM (K060361)Stryker Spine2006-03-06
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER (K051617)Novabone Products, LLC2006-03-06
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM (K060009)Abbott Spine, Inc.2006-03-06
ATHROCARE TOPAZ ARTHROWANDS (K053567)Arthrocare Corp.2006-03-06
EBI ANTERIOR CERVICAL PLATE SYSTEM (K060379)Ebi, L.P.2006-03-06
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM (K060209)Tornier2006-03-02
STRYKER INJECTABLE CEMENT (K060061)Stryker Corp.2006-03-01
U2 TOTAL KNEE SYSTEM (K051640)United Orthopedic Corp.2006-03-01
DRLOCK DISTAL RADIUS VOLAR SYSTEM (K053182)Orthohelix Surgical Designs, Inc.2006-02-27
MIIG SR (K060011)Wrightmedicaltechnologyinc2006-02-27
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS (K053340)Zimmer Trabecular2006-02-27
SHOULDER FIXATION SYSTEM (K060290)Hand Innovations, LLC2006-02-27
DISC-FX SYSTEM (K052241)Ellman International, Inc.2006-02-24
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM (K060350)Blackstone Medical, Inc.2006-02-24
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K060017)Mako Surgical Corp.2006-02-23
BIO-MINI REVO SUTURE ANCHOR (K053561)Conmed Linvatec2006-02-23
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR (K053344)Smith & Nephew, Inc.2006-02-23
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. (K060253)Regeneration Technologies, Inc.2006-02-23
TRANSET SYSTEM (K060283)Bonutti Research, Inc.2006-02-22
XR-SERIES BI-METRIC FEMORAL COMPONENTS (K052089)Biomet Manufacturing, Inc.2006-02-17
ARX SPINAL SYSTEM (K051525)Amedica Corp.2006-02-17
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM (K053581)Nuvasive, Inc.2006-02-17
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS (K053293)Ortho Development Corp.2006-02-16
OSS-BODIES PROXIMAL TIBIAL SLEEVE (K060131)Biomet Manufacturing Corp2006-02-15
VERSYS EPOCH FULLCOAT HIP PROSTHESIS (K052321)Zimmer, Inc.2006-02-15
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K060203)Medtronic Sofamor Danek2006-02-13
BASIS SPINAL SYSTEM (K060081)Medtronic Sofamor Danek2006-02-13
SYNFIX-LR (K053508)Synthes Spine Co.Lp2006-02-13
CONTOUR II SPINAL SYSTEM (K053070)Altiva Corp.2006-02-13
OPTECURE (K050806)Exactech, Inc.2006-02-08
TRIMED BONE PLATES (K060041)TriMed, Inc.2006-02-07
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K060107)Exactech, Inc.2006-02-06
COLUMBUS (CR) TOTAL KNEE SYSTEM (K053390)Aesculap, Inc.2006-02-06
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 (K053094)Advanced Bio-Surfaces, Inc.2006-02-06
AEGIS ANTERIOR LUMBAR PLATE SYSTEM (K052546)Depuy Spine, Inc.2006-02-03
EZLOC FEMORAL FIXATION DEVICE (K053461)Arthrotek, Inc.2006-02-03
MODIFICATION TO S4 SPINAL SYSTEM (K060152)Aesculap, Inc.2006-02-03
THERIGRAFT TCP PUTTY BONE VOID FILLER (K053228)Therics, LLC2006-01-31
DEPUY MODULAR M HEADS (K060031)DePuy Orthopaedics, Inc.2006-01-31
PROFEMUR XTR HIP STEM (K052915)Wrightmedicaltechnologyinc2006-01-27
REPROCESSED EXTERNAL FIXATION DEVICES (K052918)Alliance Medical Corp.2006-01-27
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS (K053338)Arthrex, Inc.2006-01-26
SIMPLEX P SPEEDSET BONE CEMENT (K053198)Howmedica Osteonics Corp.2006-01-26
NEXA COMPRESSION SCREW (K060071)Nexa Orthopedics, Inc.2006-01-26
TRIATHLON TOTAL KNEE SYSTEM (K053514)Stryker Orthopaedics2006-01-26
KOBY SURGICAL INTERNAL FIXATION SYSTEM (K060026)Koby Surgical2006-01-26
OSTEOSET DBM PELLETS (K053642)Wrightmedicaltechnologyinc2006-01-26
OSSIMEND (TM) BONE GRAFT MATERIAL (K052812)Collagen Matrix, Inc.2006-01-25
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS (K053180)Arthrocare Corp.2006-01-25
ANATOMICAL SHOULDER INVERSE/REVERSE (K053274)Zimmer GmbH2006-01-25
MBCP (K051774)Biomatlante2006-01-20
ESKA-LIBUR HIP STEM (K053557)Eska Implants GmbH & Co.2006-01-20
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS (K053292)Scient'X USA, Inc.2006-01-19
T-PIN (K053513)Union Surgical, LLC2006-01-13
DBX STRIP (K042829)Musculoskeletal Transplant Foundation2006-01-13
ENDIUS ATAVI SYSTEM (K053267)Endius, Inc.2006-01-13
PROFEMUR LX HIP STEM (K053588)Wrightmedicaltechnologyinc2006-01-13
SHORT CITATION FEMORAL STEM (K053528)Stryker Orthopaedics2006-01-13
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM (K053472)Howmedica Osteonics Corp.2006-01-11
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY (K052566)Abbott Spine, Inc.2006-01-06
CD HORIZON SPINAL SYSTEM (K053474)Medtronic Sofamor Danek2006-01-06
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT (K053445)DePuy Orthopaedics, Inc.2006-01-06
5TH METATARSAL FRACTURE SCREW (K053136)Wrightmedicaltechnologyinc2006-01-05
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K053483)Medtronic Sofamor Danek2006-01-05
CD HORIZON SPINAL SYSTEM (K053101)Medtronic Sofamor Danek2006-01-05
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT (K053299)Biomet Manufacturing, Inc.2006-01-05
ENCORE CLP OFFSET TOTAL HIP SYSTEM (K052320)Encore Medical Corporation2005-12-30
STRYKER INJECTABLE CEMENT (K051603)Stryker Leibinger Micro Implants2005-12-30
ALLOCRAFT DBM (K052735)Lifecell Corp.2005-12-28
IST PEDICLE SCREW SYSTEM (K053276)Innovative Spinal Technologies, Inc.2005-12-27
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) (K052787)Exactech, Inc.2005-12-27
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265)Smith & Nephew, Inc.2005-12-27
TANGORS POLYAXIAL SYSTEM (K052385)Ulrich GmbH & Co. KG2005-12-27
STRYKER COMPARTMENTAL KNEE SYSTEM (K052917)Howmedica Osteonics Corp.2005-12-27
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K053051)Vanguard Medical Concepts, Inc.2005-12-22
NEXA BONE PLATE AND SCREW SYSTEM (K053408)Nexa Orthopedics, Inc.2005-12-22
SEASPINE VBR SYSTEM (K052170)Seaspine, Inc.2005-12-21
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM (K052810)Scandius Biomedical, Inc.2005-12-20
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K052906)Zimmer, Inc.2005-12-19
MASTERGRAFT PUTTY BONE VOID FILLER (K051386)Medtronic Vascular2005-12-16
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