meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2013-06-07

Clearances · page 68 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K130185 4WEB OSTEOTOMY BONE WEDGE 4-Web, Inc. HRS Class II 2013-06-07
K130149 U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE United Orthopedic Corporation LPH Class II 2013-06-06
K131321 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA OSH Class II 2013-06-05
K130427 PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM Pioneer Surgical Technology, Inc. KWQ Class II 2013-06-05
K130640 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek USA, Inc. KWQ Class II 2013-06-04
K124012 INFILL OBLIQUE TLIF DEVICE Pinnacle Spine Group, LLC MAX Class II 2013-06-04
K130954 ARS SCREW; SLANT SCREW Advanced Interventional Technology, LLC HWC Class II 2013-05-31
K130319 MEDLINE CANNULATED SCREW Medline Industries, Inc. HWC Class II 2013-05-31
K130412 OSTEOMED EXTREMIFUSE SYSTEM Osteomed HWC Class II 2013-05-31
K123380 STRIDE UNICONDYLAR KNEE Blue Belt Technologies, Inc. HSX Class II 2013-05-31
K130129 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM Arthrex, Inc. KWS Class II 2013-05-31
K131324 MAXTORQUE SCREW SYSTEM Orthohelix Surgical Designs, Inc. HWC Class II 2013-05-31
K130267 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNH Class II 2013-05-31
K130498 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc. MBP Class II 2013-05-31
K131132 PELVIS II IMPLANT SYSTEM Stryker Trauma AG HRS Class II 2013-05-31
K130699 ALEUTIAN SPINAL SYSTEM K2m, Inc. MAX Class II 2013-05-30
K131216 RAMPART O Spineology, Inc. MAX Class II 2013-05-30
K130343 CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS Corin USA LZO Class II 2013-05-28
K123619 INTRABLOCK BIOBALL HIP SYSTEM (IBS) Merete Medical GmbH LZO Class II 2013-05-24
K130917 HEALIX ADVANCE KNOTLESS BR ANCHOR Depuy Mitek, A Johnson & Johnson Company MAI Class II 2013-05-24
K122639 SYNTHES SYNCAGE EVOLUTION SPACER Synthes (USA) Products, LLC MAX Class II 2013-05-24
K122801 PROVIDENCE CERVICAL CAGE Providence Medical Technology, Inc. ODP Class II 2013-05-24
K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM Wrightmedicaltechnologyinc LZO Class II 2013-05-24
K123569 ANTEGRADE FEMORAL NAIL Advanced Orthopaedic Solutions, Inc. HSB Class II 2013-05-24
K130634 CORIN METAFIX HIP STEM Corin USA LZO Class II 2013-05-24
K131156 LANX SPINAL FIXATION SYSTEM Lanx, Inc. KWP Class II 2013-05-24
K123692 PIPELINE KNEE SYSTEM Pipeline Orthopedics JWH Class II 2013-05-24
K131019 ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2013-05-24
K130430 IVAS 10MM AND 15MM BALLOON CATHETER Stryker Corporation HRX Class II 2013-05-23
K131093 ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM Wrightmedicaltechnologyinc HRS Class II 2013-05-21
K130539 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) Depuy Mitek, A Johnson & Johnson Company MBI Class II 2013-05-21
K131119 SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc. NKB Class II 2013-05-21
K130146 SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM Synthes (Usa), LLC NDN Class II 2013-05-20
K124034 MECTALIF ANTERIOR Medacta International OVD Class II 2013-05-17
K130533 SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS Tornier S.A.S. HSN Class II 2013-05-17
K130105 RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM Depuy Mitek, A Johnson & Johnson Company HTY Class II 2013-05-17
K122777 NBX - NON BRIDGING EXTERNAL FIXATOR HAND Nutek Orthopaedics, Inc. KTT Class II 2013-05-15
K130479 ILIZAROV DRILL TIP WIRES Smith & Nephew, Inc. KTT Class II 2013-05-14
K124022 SPEED SHIFT Biomedical Enterprises, Inc. JDR Class II 2013-05-14
K124058 CREO STABILIZATION SYSTEM Globus Medical, Inc. OSH Class II 2013-05-13
K123913 LATIS SPACER Globus Medical, Inc. MAX Class II 2013-05-13
K122635 TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR Tornier, Inc. MAI Class II 2013-05-13
K130506 IMSE P-TLIF Institute of Musculoskeletal Science & Education MAX Class II 2013-05-13
K130830 INTEGRA LAMINOPLASTY SYSTEM Seaspine, Inc. NQW Class II 2013-05-09
K131030 RANGE SPINAL SYSTEM K2m, Inc. OSH Class II 2013-05-09
K130661 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc. PHX Class II 2013-05-09
K130964 GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. HRS Class II 2013-05-08
K130655 RESPONSE SPINE SYSTEM OrthoPediatrics Corp. OSH Class II 2013-05-08
K122877 RANGE SPINAL SYSTEM, SMALL STATURE K2m, Inc. OSH Class II 2013-05-08
K130825 AZURE ANTERIOR CERVICAL PLATE SYSTEM Orthofix, Inc. KWQ Class II 2013-05-07
K122500 NEO PS KNEE SYSTEM Pipeline Orthopedics JWH Class II 2013-05-03
K123486 TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker MBH Class II 2013-05-03
K130334 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) Stryker Trauma AG KTT Class II 2013-05-03
K130458 KNOTLESS FIBERTAK SUTURE ANCHOR Arthrex, Inc. MBI Class II 2013-05-03
K123159 SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS Smith & Nephew, Inc. JWH Class II 2013-05-03
K123926 METASURG NITINOL STAPLE IMPLANT Metasurg JDR Class II 2013-05-03
K130632 STERISPINE PS PEDICLE SCREW Safe Orthopaedics NKB Class II 2013-05-03
K130147 ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) Small Bone Innovations, Inc. HSB Class II 2013-05-03
K130084 MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM Tgm Medical, Inc. JWH Class II 2013-05-03
K130330 RANGE SPINAL SYSTEM K2m, Inc. OSH Class II 2013-05-02
K123550 UTF STEM, REDUCED United Orthopedic Corporation LPH Class II 2013-05-01
K130434 OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC Exactech, Inc. MAX Class II 2013-05-01
K130169 FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE Depuy Mitek, A Johnson & Johnson Company HRX Class II 2013-05-01
K130899 BIOLOX DELTA CERAMIC FEMORAL HEADS Zimmer GmbH LZO Class II 2013-05-01
K120599 DEPUY M-SPEC 36MM FEMORAL HEADS Depuy Orthopaedics LPH Class II 2013-04-30
K130202 IRIS ANTERIOR CERVICAL PLATE Life Spine, Inc. KWQ Class II 2013-04-29
K113781 PANTHEON SPINAL IBFD SYSTEM Pantheon Spinal MAX Class II 2013-04-26
K130445 VAULT ALIF SYSTEM Spinal USA OVD Class II 2013-04-25
K130030 ZAVATION CERVICAL PLATE SYSTEM Zavation, LLC KWQ Class II 2013-04-25
K130590 AAP CANNULATED SCREW 2.0 Aap Implantate AG HWC Class II 2013-04-22
K130108 DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS Xiamen Double Engine Medical Material Co., Ltd. HRS Class II 2013-04-19
K130335 MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX Medtronic Sofamor Danek USA, Inc. MQV Class II 2013-04-19
K122210 NEWFIX EXTERNAL FIXATION SYSTEM Tecnologia Y Diseno Industrial, S.A DE C.V KTT Class II 2013-04-19
K123552 INSTINCT JAVA SYSTEM Zimmer Spine NKB Class II 2013-04-19
K130063 ARCOS TROCHANTER BUTTON Biomet, Inc. LPH Class II 2013-04-19
K130167 PROFEMUR XM DISTAL CENTRALIZER Wrightmedicaltechnologyinc LZO Class II 2013-04-19
K122868 BIOSPHERE BIOACTIVE BONE GRAFT PUTTY Synergy Biomedical, LLC MQV Class II 2013-04-19
K130548 EPICAGE INTERBODY FUSION DEVICE Alphatec Spine, Inc. MAX Class II 2013-04-18
K122823 SIGN PEDIATRIC FIN NAIL Sign Fracture Care International HSB Class II 2013-04-16
K123045 BRIGADE STANDALONE SYSTEM Nuvasive, Inc. OVD Class II 2013-04-16
K130673 LOSPA TOTAL KNEE REPLACEMENT SYSTEM Corentec Co., Ltd. JWH Class II 2013-04-15
K123909 AESCULAP CESPACE XP Aesculap Implant System, Inc. ODP Class II 2013-04-15
K122994 INTRAMEDULLARY NAIL SYSTEM Weigao Orthopaedic Device Co., Ltd. MNH Class II 2013-04-12
K123461 STAXX(R) IB SYSTEM Spine Wave, Inc. MAX Class II 2013-04-11
K123393 HEALICOIL SUTURE ANCHOR WITH REGENESORB Smith & Nephew, Inc. MAI Class II 2013-04-11
K123339 TK1 TOTAL KNEE SYSTEM Novosource, Inc. JWH Class II 2013-04-11
K122239 FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING Encore Medical L.P. JWH Class II 2013-04-11
K130306 INCITE ANCHORED CERVICAL INTERBODY DEVICE Incite Innovation, LLC OVE Class II 2013-04-11
K130291 S4 SPINAL SYSTEM Aesculap Implant System, Inc. NKB Class II 2013-04-11
K122455 SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM Synthes KTT Class II 2013-04-11
K130120 EXTREMITY MEDICAL IP FUSION SYSTEM Extremity Medical, LLC HWC Class II 2013-04-11
K130646 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2013-04-10
K123978 CAPSTONE L SPINAL SYSTEM Medtronic Sofamor Danek USA MAX Class II 2013-04-09
K130044 SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM Wrightmedicaltechnologyinc KTT Class II 2013-04-05
K123241 ARTHREX FRACTURE PLATES Arthrex, Inc. HRS Class II 2013-04-05
K123122 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) Cleveland Clinic KWS Class II 2013-04-05
K124027 MONSTER SCREW SYSTEM Apogee Orthosolutions HWC Class II 2013-04-05
K130340 LOCKING BONE PLATES AND SCREWS Weigao Orthopaedic Device Co., Ltd. HRS Class II 2013-04-05
K130400 MERETEC CS, CORTICAL SCREWS Merete Medical GmbH HWC Class II 2013-04-05
K123942 STRYKER IVAS BALLOON CATHETER Stryker Corporation NDN Class II 2013-04-03

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