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Orthopedic

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

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RecordFirmDate
R&D INNOVATION PEDICLE SCREW SYSTEM (K120091)R&D Innovation, LLC2012-05-18
SYNTHES MATRIX SYSTEM (K120928)Synthes Spine2012-05-18
RANGE SPINAL SYSTEM (MESA AND DENALI) (K120099)K2m, Inc.2012-05-18
GENESIS II PS NON-MODULAR FEMORAL COMPONENT (K120698)Smith & Nephew, Inc.2012-05-18
MINI CANNULATED HEADED AND HEADLESS SCREW SET (K120493)Instratek, Inc.2012-05-17
VANGUARD SSK 360 REVISION KNEE SYSTEM (K121149)Biomet Manufacturing Corp2012-05-16
S 100 PEDICLE SCREW SYSTEM (K111940)Renovis Surgical Technologies, LLC2012-05-15
SYNTHES USS CONNECTOR (K120571)Synthes Spine2012-05-14
HEALIX ADVANCE PEEK ANCHOR (K120449)Depuy Mitek2012-05-11
EOS SMALL BONE FIXATION SYSTEM (K112794)TriMed, Inc.2012-05-10
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112158)Lima Corporate S.P.A.2012-05-10
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM (K120353)Bm Korea Co., Ltd.2012-05-09
DSS STABILIZATION SYSTEM-RIGID (K120491)Paradigm Spine, LLC2012-05-09
PLATEAU SPACER SYSTEM (K121116)Life Spine2012-05-08
RELIANCE CERVICAL IBF SYSTEM (K120396)Reliance Medical Systems, LLC2012-05-08
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) (K120717)Synthes USA2012-05-08
PIONEER LATERAL PLATE SYSTEM (K120724)Pioneer Surgical Technology, Inc.2012-05-07
UNITED U2 FEMORAL COMPONENT, PS, #7 (K120507)United Orthopedic Corporation2012-05-04
KENSEY NASH BONE VOID FILLER XC (K120141)Kensey Nash Cororation2012-05-04
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY (K120362)Corin USA2012-05-04
LOSPA TIBIAL BASE PLATE (K121037)Corentec Co., Ltd.2012-05-03
ORTHOLOC 3DI HALLUX SYSTEM (K120359)Wrightmedicaltechnologyinc2012-05-03
VIPER SYSTEM (K121020)Depuy Spine, Inc.2012-05-03
FORCE MEDICAL IM NAIL SYSTEM (K102577)Force Medical, Inc.2012-05-03
MICROWARE BONE PLATES AND BONE SCREW (K111008)Microware Precision Co., Ltd.2012-05-02
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (K120978)Merete Medical GmbH2012-05-02
MONT BLANC PEDICLE SCREW SYSTEMS (K112684)Qualgenix2012-05-01
AYERS ROCK CERVICAL CAGE (K112801)Qualgenix2012-05-01
EXTERNAL FIXATOR ST.A R 90 F4 (K113384)Citieffe2012-05-01
LATERAL FUSION DEVICE (K112986)Integra Spine (Integra Lifesciences)2012-05-01
R3 XLPE LINERS (K113848)Smith & Nephew, Inc.2012-04-27
APTUS PROXIMAL HUMERUS SYSTEM (K120108)Medartis AG2012-04-27
DEPUY PULSE CERVICAL CAGE SYSTEM (K120517)Medos International SARL2012-04-26
SOLITAIRE-C CERVICAL SPACER SYSTEM (K113796)Ebi, LLC2012-04-26
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS (K112611)Sintea Plastek, LLC2012-04-25
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK (K113760)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012-04-25
MILAGRO INTERFERENCE SCREWS (K120589)Depuy Mitek, A Johnson & Johnson Company2012-04-24
APEX KIRSCHNER WIRES AND STEINMANN PINS (K121004)Apex Tools & Orthopedics Co.2012-04-24
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION (K120645)Wrightmedicaltechnologyinc2012-04-24
OSTEOMED WRIST PLATING SYSTEM (K120015)Osteomed LP2012-04-24
NEO CR KNEE SYSTEM (K120313)Pipeline Orthopedics2012-04-20
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC (K120942)Parcus Medical, LLC2012-04-20
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120063)L&K BIOMED Co., Ltd.2012-04-19
MODULAR PROXIMALLY FLUTED HIP STEM (K113789)Smith & Nephew, Inc.2012-04-19
OTIS-C PLUS (K120818)Science For Biomaterials2012-04-19
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K120316)Conformis, Inc.2012-04-19
TWIN PEAKS LUMBAR CAGE (K112696)Qualgenix, LLC2012-04-18
VERSAFITCUP CC TRIO-ADDITIONAL LINERS (K120531)Medacta International2012-04-18
INTRAOSSEOUS FIXATION SYSTEM (K120165)Orthohelix Surgical Designs, Inc.2012-04-17
NEXTGEN ALTIUS OCT SYSTEM (K113593)Biomet Spine (Aka Ebi, LLC)2012-04-17
OP SPINE SYSTEM (K120291)OrthoPediatrics Corp.2012-04-16
TRANSCORP SPINAL ACCESS SYSTEM (K113352)Transcorp, Inc.2012-04-16
ESCALATE LAMINOPLASTY SYSTEM (K113802)Stryker Spine2012-04-16
PLYMOUTH THORACOLUMBAR PLATE SYSTEM (K120092)Globus Medical, Inc.2012-04-13
ASCEND SHOULDER SYSTEM (K120794)Tornier, Inc.2012-04-13
CAPLOX II PEDICLE SCREW SYSTEM (K120292)Captiva Spine, Inc.2012-04-13
TITAN MODULAR TOTAL SHOULDER SYSTEM (K112438)Ascension Orthopedic2012-04-11
MINI MAXLOCK EXTREME PLATING SYSTEM (K120157)Orthohelix Surgical Designs, Inc.2012-04-10
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (K120390)Solana Surgical, LLC2012-04-10
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (K112481)Ascension Orthopedic2012-04-09
CAPSTONE CONTROL SPINAL SYSTEM (K120368)Medtronic Sofamor Danek USA, Inc.2012-04-09
NANOFUSE DBM (K120279)Nanotherapeutics2012-04-06
CERVICAL PLATE (K113170)Eisertech, LLC2012-04-06
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM (K120570)Choicespine, LP2012-04-05
2GC HIP/KNEE MODULAR SPACER (K112470)Mandell Horwitz Consultants, LLC2012-04-05
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT (K120667)Smith & Nephew, Inc.2012-04-04
EVEREST SPINAL SYSTEM (K120656)K2m, Inc.2012-04-04
SECURIS SPINAL FIXATION (K113361)Cumtom Spine2012-04-03
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) (K112982)Small Bone Innovations, Inc.2012-04-02
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE (K113829)Materialise NV2012-04-02
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS (K120802)Wrightmedicaltechnologyinc2012-04-02
TIGER SPINE SYSTEM (K120696)Corelink, LLC2012-04-02
TIGER SPINE SYSTEM (K113058)Corelink, LLC2012-03-29
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K113327)Stryker Corp.2012-03-29
LOCKING COMPRESSION PLATE SYSTEM (K112798)Shanghai Microport Orthopedics Co., Ltd.2012-03-29
ACCOLADE II HIP STEM (K120578)Howmedica Osteonics2012-03-29
ELLIPSE PRECICE TRAUMA NAIL SYSTEM (K113695)Ellipse Technologies, Inc.2012-03-28
REXIOUS HOOK FIXATION SYSTEMS (K113324)Dio Medical Co., Ltd.2012-03-28
ZAVATION IBF SYSTEM (K120576)Zavation, LLC2012-03-28
ZIMMER PERSONA KNEE SYSTEM (K113369)Zimmer, Inc.2012-03-27
INDEPENDENCE SPACER (K120101)Globus Medical, Inc.2012-03-27
MULTIFIX P KNOTLESS FIXATION DEVICE (K120096)ArthroCare Corporation2012-03-27
VENUS SPINAL FIXATION SYSTEM (K120270)L&K BIOMED Co., Ltd.2012-03-26
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX (K113733)Neoortho Produtos Ortopedicos S/A2012-03-23
PALLS M SPINAL SYSTEM (K120538)Korea Bone Bank Co., Ltd.2012-03-23
APACERAM BONE GRAFT SUBSTITUTE (K120602)Hoya Corporation2012-03-23
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)Synthes USA2012-03-21
NEWDEAL INTERPHALANGEAL IMPLANT (K103623)Newdeal Sas2012-03-20
BIOBOLT (K120540)Arthrex, Inc.2012-03-20
PIPELINE CR PRIMARY KNEE SYSTEM (K113122)Pipeline Orthopedics2012-03-20
METHA HIP SYSTEM (K112682)Aesculap Implant Systems, LLC2012-03-19
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 (K120557)Biomet Spine & Bone Healing Technologies2012-03-19
CHESAPEAKE SPINAL SYSTEM (K120031)K2m, Inc.2012-03-16
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 (K113320)Exactech, Inc.2012-03-16
B-GENIN, R-GENIN (K113791)Berkeley Advanced Biomaterials, Inc.2012-03-15
CITIEFFE TITANIUM NAILING SYSTEM (K113387)Citieffe2012-03-15
FOUNDATION SPINAL SYSTEM (K120074)The Skeletal Design Partnership , Ltd.2012-03-14
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE (K111820)Bm Korea Co., Ltd.2012-03-14
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA (K113756)Encore Medical L.P.2012-03-14
AILERON INTERSPINOUS FIXATION SYSTEM (K113157)Life Spine2012-03-13
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