meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2012-07-06

Clearances · page 73 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121096 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd. MAX Class II 2012-07-06
K120807 SYNTHES MULTILOC HUMERAL NAILING SYSTEM Synthes USA Products, LLC HSB Class II 2012-07-06
K121601 SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE Synthes USA HRS Class II 2012-07-06
K121683 ACCULIF TL CAGE Coalign Innovations, Inc. MAX Class II 2012-07-05
K121680 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2012-07-05
K120739 AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. PHX Class II 2012-07-05
K121060 SPINE FRONTIER INDUS ACP SYSTEM Spinefrontier, Inc. KWQ Class II 2012-07-03
K120966 DEPUY PULSE LUMBAR CAGE SYSTEM Medos International SARL MAX Class II 2012-07-03
K120177 SPINAL ELEMENTS CERCLAGE SYSTEM Spinal Elements, Inc. JDQ Class II 2012-07-03
K121107 FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) Globus Medical, Inc. MQP Class II 2012-07-03
K121333 WAVE D CAGE Advanced Medical Technologies AG MAX Class II 2012-06-29
K120990 NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL Zimmer Trabecular Metal Technology MBH Class II 2012-06-29
K121330 WAVE O CAGE Advanced Medical Technologies AG MAX Class II 2012-06-29
K111785 FREEDOM(R) STEMMED TIBIAL COMPONENTS Maxx Orthopedics, Inc. JWH Class II 2012-06-29
K121332 LOOP CAGE Advanced Medical Technologies AG MAX Class II 2012-06-29
K121288 FUSE CAGE Advanced Medical Technologies AG MAX Class II 2012-06-29
K121191 VERTEX RCCONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2012-06-29
K120918 NUVASIVE COROENT TITANIUM SYSTEM Nuvasive, Inc. MAX Class II 2012-06-28
K120760 LDR SPINE SPINETUNE TL SPINAL SYSTEM Ldr Spine USA, Inc. MNH Class II 2012-06-27
K121049 UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2012-06-27
K121016 RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. MNH Class II 2012-06-27
K121211 VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC OVD Class II 2012-06-27
K120680 ENSPIRE DISCECTOMY SYSTEM Spine View, Inc. HRX Class II 2012-06-26
K113383 XTRAFIX EXTERNAL FIXATION SYSTEM Extraortho, Inc. KTT Class II 2012-06-26
K121342 XIA 4.5 SPINAL SYSTEM Stryker Corp. NKB Class II 2012-06-22
K121018 BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN Smith & Nephew, Inc. MBI Class II 2012-06-22
K112809 BLUE MOUNTAIN CERVICAL PLATE Qualgenix, LLC KWQ Class II 2012-06-20
K121493 ASCEND SHOULDER SYSTEM Tornier, Inc. KWS Class II 2012-06-20
K121024 LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; Encore Medical L.P. LPH Class II 2012-06-19
K112030 SYNTHES RADIAL HEAD PROSTHESIS SYSTEM Synthes USA, LLC KWI Class II 2012-06-19
K121250 OP SPINE SYSTEM OrthoPediatrics Corp. OSH Class II 2012-06-19
K120854 SYNTHES VA LCP ANKLE TRAUMA SYSTEM Synthes USA HRS Class II 2012-06-18
K121246 MEDYSSY LT CAGE SYSTEM Medyssey Co, Ltd. MAX Class II 2012-06-15
K120203 TM-400 DEVICE Zimmer Trabecular Metal Technology, Inc. MAX Class II 2012-06-15
K111863 SIGNATURE PLANNER,SIGNATURE GUIDES Materialise NV JDI Class II 2012-06-15
K121130 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS Biomet Spine NKB Class II 2012-06-15
K113395 REVERE 4.5 STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2012-06-14
K111136 EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM Depuy Spine, Inc. NKB Class II 2012-06-14
K121437 MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2012-06-13
K112897 RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS Renovis Surgical Technologies, LLC OQG Class II 2012-06-13
K120345 HONOUR SPACER SYSTEM Nexxt Spine, LLC ODP Class II 2012-06-13
K121129 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. MAX Class II 2012-06-13
K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE Zimmer GmbH HRS Class II 2012-06-12
K120174 DEPUT DELTA XTEND REVERSE SHOULDER Depuy France PHX Class II 2012-06-11
K120790 GMK - LINE EXTENSION Medacta International JWH Class II 2012-06-08
K121011 AMISTEM AND QUADRA - LINE EXTENSION Medacta International LZO Class II 2012-06-08
K120871 SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION Smith & Nephew, Inc. JDW Class II 2012-06-07
K112607 SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... Spinevision S.A. NKB Class II 2012-06-07
K120841 APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR Kfx Medical MBI Class II 2012-06-07
K120646 CAPSURE(R) PS SYSTEM Spine Wave, Inc. MNI Class II 2012-06-07
K113388 CITIEFFE-TITANIUM CANNULATED SCREW Citieffe HWC Class II 2012-06-05
K121008 TRILLIANT SURGICAL K-WIRES Trilliant Surgical, Ltd. HTY Class II 2012-06-04
K120689 SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM Synthes (USA) Products, LLC HRS Class II 2012-06-04
K120370 VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS Zimmer, Inc. OQG Class II 2012-06-04
K112900 SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS Lima Corporate S.P.A. HSD Class II 2012-06-01
K121307 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ Exactech, Inc. JWH Class II 2012-05-31
K120829 STAINLESS STEEL SPINAL SYSTEM Theken Spine, LLC NKB Class II 2012-05-30
K110472 SI-FIX SACROILIAC JOINT FUSION SYSTEM Medtronic Sofamor Danek OUR Class II 2012-05-29
K113561 TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION Zimmer Trabecular Metal Technology MAX Class II 2012-05-29
K120360 ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS Ortho Solutions Limited HRS Class II 2012-05-29
K113006 I-FUSE HAMMER TOE SYSTEMS Orthopro, LLC HWC Class II 2012-05-25
K120275 SYNTHES ACIS/VERTEBRAL SPACER CR Synthes (Usa), LLC ODP Class II 2012-05-25
K120899 RANGE SPINAL SYSTEM, UNIT ROD K2m, Inc. MNI Class II 2012-05-25
K112905 COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, LLC MBF Class II 2012-05-24
K120840 LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd. ODP Class II 2012-05-24
K110632 LUCENT OR LUCENT MAGNUM Spinal Elements, Inc. MAX Class II 2012-05-23
K120515 TEMPUS CERVICAL PLATE SYSTEM Neurostructures, LLC KWQ Class II 2012-05-23
K120879 LEXUS CERVICAL FIXATION SYSTEM L&K BIOMED Co., Ltd. MNI Class II 2012-05-23
K121263 TAPER SET HIP SYSTEM RDP STEM Consensus Orthopedics, Inc. LPH Class II 2012-05-22
K120419 DYNA LOCKING ANKLE NAIL U&I Corp. HSB Class II 2012-05-21
K113271 METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS Biomet Manufacturing, Inc. KWA Class III 2012-05-18
K120928 SYNTHES MATRIX SYSTEM Synthes Spine NKB Class II 2012-05-18
K120099 RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. MNI Class II 2012-05-18
K120091 R&D INNOVATION PEDICLE SCREW SYSTEM R&D Innovation, LLC NKB Class II 2012-05-18
K120698 GENESIS II PS NON-MODULAR FEMORAL COMPONENT Smith & Nephew, Inc. JWH Class II 2012-05-18
K120493 MINI CANNULATED HEADED AND HEADLESS SCREW SET Instratek, Inc. HWC Class II 2012-05-17
K121149 VANGUARD SSK 360 REVISION KNEE SYSTEM Biomet Manufacturing Corp JWH Class II 2012-05-16
K111940 S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC MNH Class II 2012-05-15
K120571 SYNTHES USS CONNECTOR Synthes Spine NKB Class II 2012-05-14
K120449 HEALIX ADVANCE PEEK ANCHOR Depuy Mitek HWC Class II 2012-05-11
K112794 EOS SMALL BONE FIXATION SYSTEM TriMed, Inc. HRS Class II 2012-05-10
K112158 MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS Lima Corporate S.P.A. LPH Class II 2012-05-10
K120353 SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM Bm Korea Co., Ltd. MNH Class II 2012-05-09
K120491 DSS STABILIZATION SYSTEM-RIGID Paradigm Spine, LLC MNH Class II 2012-05-09
K121116 PLATEAU SPACER SYSTEM Life Spine MAX Class II 2012-05-08
K120396 RELIANCE CERVICAL IBF SYSTEM Reliance Medical Systems, LLC ODP Class II 2012-05-08
K120717 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) Synthes USA HRS Class II 2012-05-08
K120724 PIONEER LATERAL PLATE SYSTEM Pioneer Surgical Technology, Inc. KWQ Class II 2012-05-07
K120507 UNITED U2 FEMORAL COMPONENT, PS, #7 United Orthopedic Corporation JWH Class II 2012-05-04
K120141 KENSEY NASH BONE VOID FILLER XC Kensey Nash Cororation MQV Class II 2012-05-04
K120362 METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY Corin USA LZO Class II 2012-05-04
K121037 LOSPA TIBIAL BASE PLATE Corentec Co., Ltd. JWH Class II 2012-05-03
K102577 FORCE MEDICAL IM NAIL SYSTEM Force Medical, Inc. HSB Class II 2012-05-03
K121020 VIPER SYSTEM Depuy Spine, Inc. NKB Class II 2012-05-03
K120359 ORTHOLOC 3DI HALLUX SYSTEM Wrightmedicaltechnologyinc HRS Class II 2012-05-03
K111008 MICROWARE BONE PLATES AND BONE SCREW Microware Precision Co., Ltd. HRS Class II 2012-05-02
K120978 OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR Merete Medical GmbH HSB Class II 2012-05-02
K112684 MONT BLANC PEDICLE SCREW SYSTEMS Qualgenix NKB Class II 2012-05-01
K113384 EXTERNAL FIXATOR ST.A R 90 F4 Citieffe KTT Class II 2012-05-01
K112801 AYERS ROCK CERVICAL CAGE Qualgenix ODP Class II 2012-05-01

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