meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2011-03-18

Clearances · page 80 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110476 AXSOS (TM) LOCKING PLATE SYSTEM Stryker Corp. HRS Class II 2011-03-18
K103705 LOW PROFILE SCREWS Arthrex, Inc. HWC Class II 2011-03-18
K103742 ACCELL EVO3 (FORMERLY ACCELL A2I) Integra Life Sciences MBP Class II 2011-03-17
K110445 FLEXFUSION (TM) FIXATION IMPLANT Nextremity Solutions, LLC HWC Class II 2011-03-17
K103440 EVEREST SPINAL SYSTEM K2m, Inc. MNI Class II 2011-03-17
K103814 PEZO INTERBODY CAGES SYSTEM Ulrich GmbH & Co. KG MAX Class II 2011-03-17
K103743 CONCORDE CURVE SYSTEM Johnson & Johnson MAX Class II 2011-03-17
K103072 REVERE SACRAL PLATES Globus Medical, Inc. NKB Class II 2011-03-17
K103384 ESCALADE ACETABULAR CUP SYSTEM Ortho Development LPH Class II 2011-03-16
K101374 AAXTER A3 POSTERIOR SPINAL SYSTEM Aaxter Co., Ltd. MNH Class II 2011-03-16
K103756 DEPUY ATTUNE TOTAL KNEE SYSTEM DePuy Orthopaedics, Inc. OIY Class II 2011-03-15
K103505 ALTUM ANTERIOR CERVICAL PLATE Spinecraft, LLC KWQ Class II 2011-03-15
K101930 MEMOMETAL NAVIS BONE PLATING SYSTEM Memometal Technologies HRS Class II 2011-03-15
K103404 ANA0TOMICAL SHOULDER TM COMBINED SYSTEM Zimmer GmbH KWT Class II 2011-03-15
K102334 TRANS1 AXIALIF PLUS Trans1 Incorporated KWQ Class II 2011-03-14
K100698 STCC Cardinal Spine, LLC ODP Class II 2011-03-14
K101338 NEWFIX EXTERNAL FIXATION SYSTEM Technologia Y Diseno Industrial, S.A DE C.V KTT Class II 2011-03-14
K103712 GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD Depuy Mitek, A Johnson & Johnson Company HWC Class II 2011-03-11
K103479 NOVEL TAPERED HIP STEM Stryker Corp. MEH Class II 2011-03-10
K093736 DEPUY CORAIL HIP SYSTEM, REVISION STEM DePuy Orthopaedics, Inc. LZO Class II 2011-03-10
K103518 TRINITY ACETABULAR SYSTEM Corin USA LWJ Class II 2011-03-09
K102574 PALLA M SPINAL SYSTEM Korea Bone Bank Co., Ltd. MNH Class II 2011-03-07
K101790 QUANTUM SPINAL SYSTEM, QUANTUM MIS Pioneer Surgical Technology NKB Class II 2011-03-07
K100370 SYMMETRIC TOTAL KNEE AGUMENTS Signal Medical Corp. JWH Class II 2011-03-07
K103169 ALEUTTIAN K2m, Inc. ODP Class II 2011-03-07
K110322 OLECRA INTRAMEDULLARY FIXATION SYSTEM Mylad Orthopedic Solutions HSB Class II 2011-03-04
K103497 CERAMIC FEMORAL HEAD United Orthopedic Corp. MEH Class II 2011-03-04
K103292 TRIO TRAUMA SPINAL SYSTEM Stryker Corporation NKB Class II 2011-03-04
K110145 BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Biomet, Inc. MBI Class II 2011-03-04
K110354 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM Synthes USA JDP Class II 2011-03-04
K103750 NUVASIVE TRAVERSE PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2011-03-03
K102580 VANGUARD REMOVABLE MOLDED POLY TIBIA Biomet Manufacturing Corp JWH Class II 2011-03-03
K102019 RESTORATION ACETABULAR WEDGE AUGMENTS Howmedica Osteonics LPH Class II 2011-03-03
K102636 ZENITH PEDICLE SYSTEM Apollo Spine, Inc. MNH Class II 2011-03-03
K103748 LAGUNA PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2011-03-02
K103002 SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM Synthes (Usa) HSB Class II 2011-03-02
K103488 CONCORDE BULLET CAGE SYSTEM Johnson and Johnson MAX Class II 2011-03-02
K102172 MSA HIP SYSTEM Global Manufacturing Technology MEH Class II 2011-03-01
K110362 VANGUARD ASYMMETRICAL PATELLAR COMPONENT Biomet Manufacturing Corp JWH Class II 2011-02-28
K103660 LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Lanx, Inc. ODP Class II 2011-02-28
K110047 VERTICOR K-WIRE SYSTEM Verticor, Ltd. HTY Class II 2011-02-28
K103120 CORIN BIOLOX DELTA FEMORAL HEADS Corin USA LZO Class II 2011-02-28
K102397 KYPHON XPEDE BONE CEMENT Medtronic NDN Class II 2011-02-28
K102597 PICCOLO COMPOSITE PLATE SYSTEM N.M.B. Medical Applications, Ltd. HRS Class II 2011-02-24
K102539 ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM Shoulder Options, Inc. MBI Class II 2011-02-24
K102125 PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS Biomet, Inc. JWH Class II 2011-02-23
K103383 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM Spartek Medical, Inc. NKB Class II 2011-02-17
K103001 ROCKWOOD CLAVICLE PINS DePuy Orthopaedics, Inc. JDW Class II 2011-02-17
K103490 EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM Johnson & Johnson NKB Class II 2011-02-17
K110183 ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE Arthrocare Corp. NDN Class II 2011-02-16
K103517 TRABECULAR METAL FEMORAL CONE AUGMENTS Zimmer Trabecular Metal Technology, Inc. MBH Class II 2011-02-15
K103838 FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM Precision Surgery , Ltd. KWQ Class II 2011-02-15
K091207 SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE Surgicraft , Ltd. HTN Class II 2011-02-15
K103819 PSL ANTERIOR CERVICAL PLATE SYSTEM Precision Surgery , Ltd. KWQ Class II 2011-02-15
K110176 AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS Howmedica Osteonics Corp., Dba Stryker Orthopaedics HRS Class II 2011-02-15
K103491 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM A Johnson & Johnson Company KWQ Class II 2011-02-14
K101818 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. MNH Class II 2011-02-11
K103352 VERSAFITCUP CC TRIO Medacta International LZO Class II 2011-02-11
K102449 BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM Bright Spine, Inc. ODP Class II 2011-02-11
K103137 VENUS ANTERIOR CERVICAL PLATE Verticor, Ltd. KWQ Class II 2011-02-10
K102738 LANX FUSION SYSTEM Lanx, LLC OVD Class II 2011-02-10
K103145 HAMMERLOC TM TIBIAL FIXATION DEVICE Biomet Sports Medicine MBI Class II 2011-02-09
K100945 FUSE PLIF CAFE Advanced Medical Technologies AG MAX Class II 2011-02-09
K103085 VENUS BASIC SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd. MNH Class II 2011-02-09
K103102 LEUCADIA PEDICLE SCREW SYSTEM Phygen, LLC MNI Class II 2011-02-08
K110069 SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE Smith & Nephew, Inc. KTT Class II 2011-02-08
K103183 TRILLIANT SURGICAL SUBTALAR IMPLANT Trilliant Surgical, Ltd. HWC Class II 2011-02-08
K103040 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) Lanx, LLC NKB Class II 2011-02-08
K103173 VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE Orthovita, Inc. MQV Class II 2011-02-07
K110164 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL Arthrocare Corp. MBI Class II 2011-02-07
K102547 COROENT INTERLOCK SYSTEM Nuvasive, Inc. OVE Class II 2011-02-07
K103816 COHESION BONE CEMENT Teknimed Sas NDN Class II 2011-02-04
K101353 GOLDEN GATE ANTERIOR PLATE SYSTEM Ulrich GmbH & Co. KG KWQ Class II 2011-02-04
K110045 INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE Vertebral Technologies, Inc. MAX Class II 2011-02-03
K103233 MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT Howmedica Osteonics Corp. LZO Class II 2011-02-03
K103309 OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS Smith & Nephew Endoscopy, Inc. MAI Class II 2011-02-03
K102795 SIGNATURE PLANNER; SIGNATURE GUIDES Materialise NV JWH Class II 2011-02-02
K102995 TALON SPINAL SYSTEM Spine360 MNI Class II 2011-02-02
K103393 POLARIS SPINAL SYSTEM Biomet Spine KWQ Class II 2011-02-02
K103256 SMITH & NEPHEW SMF HIP STEM Smith & Nephew, Inc. LPH Class II 2011-01-31
K102369 PICCOLO COMPOSITE NAILING SYSTEM N.M.B. Medical Applications, Ltd. HSB Class II 2011-01-31
K103208 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM Encore Medical L.P. PHX Class II 2011-01-31
K102924 AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM Tornier, Inc. KWS Class II 2011-01-31
K101263 LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, Lima-Lto S.P.A. KWT Class II 2011-01-28
K101459 OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 Smith & Nephew, Inc. MAI Class II 2011-01-27
K102722 NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY Synthes USA Products, LLC MQV Class II 2011-01-27
K103297 REDONDO-L Seaspine, Inc. MAX Class II 2011-01-27
K102927 CONSENSUS KNEE SYSTEM Consensus Orthopedics, Inc. MBH Class II 2011-01-26
K102886 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2011-01-26
K102853 FLAMENCO SPINAL FIXATION SYSTEM Ulrich GmbH & Co. KG MNH Class II 2011-01-25
K101171 ORTHOVITA PEEK SPACER Orthovita, Inc. ODP Class II 2011-01-25
K103231 KYPHON INFLATION SYRINGE Medtronic Spine, LLC HRX Class II 2011-01-24
K103332 APTUS ULNA PLATES Medartis AG HRS Class II 2011-01-24
K102670 TOTAL SHOULDER SYSTEM Shoulder Innovations, LLC KWS Class II 2011-01-24
K103243 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa) HRS Class II 2011-01-21
K102870 EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM Exactech, Inc. MNH Class II 2011-01-21
K103755 TAPERLOC COMPLETE, SIZE 5 AND 6 Biomet Manufacturing Corp KWA Class III 2011-01-21
K101446 EMERALD SPINAL SYSTEM Mazor Surgical Technologies , Ltd. MNH Class II 2011-01-20
K102195 SP-FIX SPINOUS PROCESS FIXATION PLATE Globus Medical, Inc. KWP Class II 2011-01-19
K103533 ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM Advanced Orthopaedic Solutions, Inc. HSB Class II 2011-01-19

17,115 clearances in the Orthopedic panel. Data: openFDA.