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Orthopedic

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

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RecordFirmDate
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T (K132241)Depuy Mitek, A Johnson & Johnson Company2013-11-05
MECTACER BIOLOX OPTION HEADS (K131518)Medacta International2013-11-04
WOLF LONG BONE PLATE SYSTEM (K131834)Toby Orthopaedics2013-11-04
ARIX HAND SYSTEM (K131566)Jeil Medical Corporation2013-11-04
PERIMETER INTERBODY FUSION DEVICE (K131669)Medtronic Sofamor Danek USA, Inc.2013-11-01
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) (K132883)Hemodia Sas2013-11-01
ALTUS SPINE PEDICLE SCREW SYSTEM (K132280)Altus Partners2013-10-31
GSB GLOBAL SPINAL BALANCE SYSTEM (K132014)Nuvasive, Inc.2013-10-31
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER (K131116)United Orthopedic Corporation2013-10-30
ARTHREX UNIVERS II CA HEADS (K130675)Arthrex, Inc.2013-10-30
FLOWER BONE SCREW SET (K132248)Flower Orthopedics Corporation2013-10-30
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (K122783)Aesculap Implant System, Inc.2013-10-30
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM (K130274)Elite Surgical Supplies (Pty), Ltd.2013-10-29
2.5MM INLINE FUSION PLATE (K131867)Biomet, Inc.2013-10-29
REVERSE SHOULDER PROSTHESIS MONOBLOCK (K130048)Encore Medical L.P.2013-10-29
NAUTILUS SPINAL SYSTEM (K132866)Life Spine, Inc.2013-10-28
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132900)Intelligent Implant Systems, LLC2013-10-25
LOTUS (K131427)Spinal Elements, Inc.2013-10-24
MAK OSS FEMORAL KNEE COMPONENTS (K131393)Biomet Orthopedics Corp.2013-10-24
BIOPRO - INFINITY PLATE ANCHOR SYSTEM (K132510)Biopro, Inc.2013-10-24
WMT IMPLANTABLE K-WIRE (K132895)Wrightmedicaltechnologyinc2013-10-23
CALIX LUMBAR SPINAL IMPLANT SYSTEM (K131350)X-Spine Systems, Inc.2013-10-23
VARIAX 2 SYSTEM (K132502)Stryker Trauma AG2013-10-23
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT (K131679)Wrightmedicaltechnologyinc2013-10-23
LESSER METATARSAL HEAD IMPLANT SYSTEM (K131187)Solana Surgical, LLC2013-10-22
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS (K132435)Smith & Nephew, Inc.2013-10-22
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS (K122437)Biomet Sports Medicine2013-10-18
TRUE SPINAL FIXATION SYSTEM (K130958)Innovative Surgical Designs2013-10-17
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE (K131459)Aap Implantate AG2013-10-17
UNIVATION (K131167)Aesculap Implant Systems, LLC2013-10-17
SMOOTH OR THREADED METALLIC BONE FASTENER (K131640)Biomedical Ent., Inc.2013-10-16
OVATION 10/12 HIP STEM (K131022)Ortho Development Corp.2013-10-16
PROW FUSION (K130254)Nlt Spine, Ltd.2013-10-16
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K131231)Tornier S.A.S.2013-10-16
A.I.M. SUTURE ANCHOR (K132461)Anchor Innovation Medical, Inc.2013-10-16
IFUSE IMPLANT SYSTEM (K131405)SI-BONE, Inc.2013-10-16
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K131677)Ellipse Technologies, Inc.2013-10-11
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS (K132161)Exactech, Inc.2013-10-11
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA (K131337)Ortho Development Corp.2013-10-11
IDYS LIF CAGES (K131178)Clariance2013-10-10
INERTIA MIS PEDICLE SCREW SYSTEM (K132412)Nexxt Spine, LLC2013-10-10
POLARUS CONNECT (K131636)Acumed, LLC2013-10-10
T2 TIBIAL NAILING SYSTEM (K131365)Stryker Trauma AG2013-10-10
BIOLOX(R) DELTA CERAMIC HEADS (K131684)Biomet, Inc.2013-10-10
IMPLANET SPINE SYSTEM (K132303)Implanet, S.A.2013-10-10
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA (K130728)Smith & Nephew, Inc.2013-10-10
CEZANNE II INTERBODY FUSION SYSTEM (K131981)Accel Spine2013-10-09
COMPREHENSIVE CONVERTIBLE GLENOID (K130390)Biomet Manufacturing, Inc.2013-10-09
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (K132704)Biomet2013-10-09
APEX KNEE MODULAR TIBIA SYSTEM (K131472)Omni Life Science, Inc.2013-10-08
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM (K131186)Synthes (USA) Products, LLC2013-10-08
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE (K131353)Biomet Manufacturing Corp2013-10-08
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) (K132589)Life Spine, Inc.2013-10-08
CD HORIZON SPINAL SYSTEM (K132471)Medtronic Sofamor Danek USA, Inc.2013-10-08
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM (K131769)Pivot Medical, Inc.2013-10-07
STAXX IBL SYSTEM (K132719)Spine Wave, Inc.2013-10-04
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G (K131820)Care Fusion2013-10-04
LOCKING PLATE SYSTEM (K132642)Beijing Libeier Bio-Engineering Institute Co., Ltd.2013-10-03
NEO KNEE SYSTEM (K131368)Pipeline Orthopedics2013-10-03
AVAFLEX VERTEBRAL BALLOON SYSTEM (K131824)Care Fusion2013-10-03
PICCOLO COMPOSITE NAILING SYSTEM (K132774)CarboFix Orthopedics , Ltd.2013-10-03
PASS LP SPINAL SYSTEM (K132575)Medicrea International2013-10-03
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 (K132554)Aap Implantate AG2013-10-03
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT (K131673)Medtronic Sofamor Danek USA, Inc.2013-10-03
EVEREST SPINAL SYSTEM (K132361)K2m, Inc.2013-10-03
NAUTILUS SPINAL SYSTEM (K132760)Life Spine, Inc.2013-10-03
MPACT DM LINER CONVERTER (K131458)Medacta International2013-10-01
TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF (K130573)Tyber Medical, LLC2013-09-30
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC (K131845)Acumed, LLC2013-09-30
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES (K131559)Materialise NV2013-09-27
TRINITY ACETABULAR SYSTEM (K131647)Corin USA2013-09-27
ARTHREX UNIVERS APEX (K131633)Arthrex, Inc.2013-09-27
PERIMETER INTERBODY FUSION DEVICE (K132700)Medtronic Sofamor Danek, Inc.2013-09-26
ARTHREX COMPRESSION PLATES (K130510)Arthrex, Inc.2013-09-25
JAZZ SYSTEM (K132287)Hogan Lovells US LLP2013-09-25
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER (K130365)Encore Medical L.P.2013-09-23
ANATOMIC PEEK CERVICAL FUSION SYSTEM (K130177)Medtronic Sofamor Danek USA, Inc.2013-09-23
RELIANCE CERVICAL IBF SYSTEM (K131429)Reliance Medical Systems, LLC2013-09-23
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE (K131888)Medtronic Sofamor Danek, Inc.2013-09-23
PIPELINE KNEE SYSTEM (K132046)Pipeline Orthopedics2013-09-23
COROENT SINGLE TAB SYSTEM (K131723)Nuvasive, Inc.2013-09-20
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER (K132513)ArthroCare Corporation2013-09-19
OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 (K132479)Interventional Spine, Inc.2013-09-19
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM (K130810)Zimmer, Inc.2013-09-19
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) (K132626)Pipeline Biotechnology2013-09-19
RENOVIS BIPOLAR HIP SYSTEM (K131354)Renovis Surgical Technologies, LLC2013-09-19
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES (K132632)Tornier, Inc.2013-09-19
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU (K132644)Corentec Co., Ltd.2013-09-19
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K131122)Renovis Surgical Technologies, LLC2013-09-18
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL (K130595)Zimmer, Inc.2013-09-17
MAXLOCK EXTREME SYSTEM (K132591)Orthohelix Surgical Designs, Inc.2013-09-17
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA (K132590)ArthroCare Corporation2013-09-17
RAMPART-O, RAMPART-T (K132053)Spineology, Inc.2013-09-16
NOVOKNEE TOTAL KNEE SYSTEM (K131398)Novosource, Inc.2013-09-16
DEPUY CORAIL AMT HIP PROSTHESIS (K123991)Depuy France S.A.S.2013-09-16
CAS PSI KNEE SYSTEM (K131409)Orthosoft, Inc.2013-09-13
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE (K130641)Binder Biomedical, Inc.2013-09-13
VIVORTE BVF (K130703)Vivorte, Inc.2013-09-12
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (K131802)Depuy Spine, A Johnson & Johnson Company2013-09-12
ACCULIF TL AND PL CAGE (K132505)Coalign Innovations, Inc.2013-09-12
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