meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
2011-10-26

Clearances · page 77 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111512 BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM Thompson Mis, Inc. MAX Class II 2011-10-26
K110998 AFFIRM (TM) VCF SYSTEM Algea Therapies NDN Class II 2011-10-25
K111965 VUSION(R) OS Ortho Development MAX Class II 2011-10-25
K112249 HEALIX KNOTLESS(TM) ANCHOR Depuy Mitek, A Johnson & Johnson Company MAI Class II 2011-10-25
K111993 FRAMEWALKER Quantum Medical Concepts, LLC KTT Class II 2011-10-24
K110783 VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE L&K BIOMED Co., Ltd. MAX Class II 2011-10-24
K103513 LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA Advanced Orthopaedic Solutions, Inc. HRS Class II 2011-10-24
K102387 MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES Mediscope Manufacturing, Inc. JDR Class II 2011-10-24
K112473 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2011-10-21
K110992 ENSPIRE DEBRIDER SYSTEM Spine View, Inc. HRX Class II 2011-10-21
K112737 TIGER HEADLESS CANNULATED SCREWS Trilliant Surgical, Ltd. HWC Class II 2011-10-20
K103320 SYNTHES XRL Synthes Spine Co.Lp MQP Class II 2011-10-20
K111155 XTRAFIX EXTERNAL FIXATION SYSTEM Extraortho, Inc. KTT Class II 2011-10-20
K111883 SMARTLOC SPINAL FIXATION SYSTEM A-Spine Asia, Co., Ltd. MNI Class II 2011-10-18
K112759 APCLO PEDICLE SCREW SYSTEMS Atlas Spine, Inc. NKB Class II 2011-10-18
K112014 ZYSTON STRAIGHT SPACER SYSTEM Biomet Spine MAX Class II 2011-10-17
K111354 GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) GS Medical Co., Ltd. MAX Class II 2011-10-17
K103598 PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc MBH Class II 2011-10-17
K112773 NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC MQV Class II 2011-10-14
K110135 POLARCUP DUAL MOBILITY SYSTEM Smith & Nephew, Inc. LPH Class II 2011-10-14
K111910 GLADIATOR HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-10-14
K110003 MTF NEW BONE VOID FILLER Musculoskeletal Transplant Foundation MQV Class II 2011-10-13
K111492 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS Materialise NV JWH Class II 2011-10-13
K112019 BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP Corentec Co., Ltd. KWY Class II 2011-10-12
K111264 CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM Medtronic Sofamor Danek USA ODP Class II 2011-10-12
K110153 SFC VERTEBRAL BODY REPLACEMENT Konigsee Implantate GmbH MQP Class II 2011-10-12
K112615 AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. PHX Class II 2011-10-11
K112254 APEX KIRSCHNER WIRES AND STEINMANN PINS Apex Tools & Orthopedics Co. HTY Class II 2011-10-11
K111994 SMITH & NEPHEW CANNULATED SCREWS AND WASHERS Smith & Nephew, Inc. HWC Class II 2011-10-11
K110694 CONCORDE BULLET SPINAL SYSTEM Johnson & Johnson MAX Class II 2011-10-11
K112756 FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS Globus Medical, Inc. MQP Class II 2011-10-07
K111419 OSTEOMED HAND FUSION SYSTEM Osteomed LP HRS Class II 2011-10-07
K112772 ORTHOLOC(TM) BONE SCREWS Wrightmedicaltechnologyinc HWC Class II 2011-10-07
K110836 CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY Zimmer GmbH KWA Class III 2011-10-07
K112115 MECTACER BIOLOX(R) DELTA FEMORAL HEADS Medacta International LZO Class II 2011-10-07
K111266 EASYLOCK OSTEOSYSTEM TriMed, Inc. HRS Class II 2011-10-06
K112037 RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. MNI Class II 2011-10-06
K111447 ZIMMER PERIARTICULAR SCREWS Zimmer, Inc. HWC Class II 2011-10-05
K111848 EXETER X3 RIMFIT ACETABULAR CUP Stryker Corp. JDI Class II 2011-10-05
K110063 SOVEREIGN SPINAL SYSTEM Medtronic Sofamor Danek, Inc. OVD Class II 2011-10-04
K111735 REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER Encore Medical L.P. PHX Class II 2011-10-03
K110400 TAPERLOC COMPLETE MICROPLASTY STEM Biomet Manufacturing Corp KWA Class III 2011-09-30
K110327 LDR SPINE ROI-A INTERBODY FUSION SYSTEM Ldr Spine USA OVD Class II 2011-09-30
K111916 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. HSX Class II 2011-09-29
K111553 SPINEFRONTIER LUMBAR IBF SYSTEM Spinefrontier, Inc. MAX Class II 2011-09-28
K112556 ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS Howmedica Osteonics Corp. MEH Class II 2011-09-28
K112496 PIONEER CROSSFUSE II IBF/VBR SYSTEM Pioneer Surgical Technology, Inc. MAX Class II 2011-09-28
K110290 EXETER HIP STEM Howmedica Osteonics Corp. JDI Class II 2011-09-27
K112555 CD HORIZON(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2011-09-27
K110800 META-LOCK SUTURE ANCHOR SYSTEM Tarsus Medical, Inc. MBI Class II 2011-09-27
K110497 PASS LP SPINAL SYSTEM Medicrea International MNH Class II 2011-09-26
K111838 INQU PASTE MIX Isto Technologies, Inc. MQV Class II 2011-09-26
K111880 SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE Spineology, Inc. MAX Class II 2011-09-26
K112463 UNITED 36MM CERAMIC FEMORAL HEAD, DELTA United Orthopedic Corporation LZO Class II 2011-09-23
K112455 AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics HRS Class II 2011-09-22
K111370 ODALYS PEDICLE SCREW SYSTEM Kalitec Direct, LLC MNH Class II 2011-09-21
K111936 ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD Ortho Development LZO Class II 2011-09-21
K101356 Spacer-G and Spacer-K Tecres S.P.A. KWL Class II 2011-09-20
K111629 TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 Encore Medical L.P. PHX Class II 2011-09-16
K111711 JOURNEY II BCS KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2011-09-16
K112025 SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM Spinal USA KWP Class II 2011-09-15
K111457 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2011-09-15
K111510 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2011-09-15
K110659 MEDICAL CONCEPTS INTERBODY FUSION SYSTEM Medical Concepts, Inc. MAX Class II 2011-09-13
K111115 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM Captiva Spine, Inc. MNI Class II 2011-09-13
K111484 DISCOVERY Intuitive Spine, LLC ODP Class II 2011-09-12
K110086 IFS PROFILE PLATES, SCREWS, AND WASHERS Internal Fixation Systems, Inc. HRS Class II 2011-09-09
K111626 ENDOSKELETON(R) TAS Titan Spine, LLC OVD Class II 2011-09-09
K111635 SMITH & NEPHEW RJ CONSTRAINED LINERS Smith & Nephew, Inc. KWZ Class II 2011-09-09
K111166 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) Spineworks, LLC MAX Class II 2011-09-08
K111729 PILOT SPINAL SYSTEM Life Spine, Inc. NKB Class II 2011-09-07
K111472 HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON Tgm Medical LPH Class II 2011-09-06
K112237 MICROSUTURE ANCHORS Arthrex, Inc. HWC Class II 2011-09-02
K110791 BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION Zimmer, Inc. KWT Class II 2011-09-02
K111032 CMC CABLE FIX Instratek, Inc. HTN Class II 2011-08-31
K111913 CAPSURE(R) PS SYSTEM Spine Wave, Inc. MNI Class II 2011-08-31
K111433 DEPUY STTUNE (TM) PS KNEE SYSTEM DePuy Orthopaedics, Inc. OIY Class II 2011-08-30
K111942 TSRH SPINAL SYSTEMS Medtronic Sofamor Danek USA, Inc. NKB Class II 2011-08-30
K111572 NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL Serf LZO Class II 2011-08-29
K103799 INQU PASTE MIX PLUS Isto Technologies, Inc. MQV Class II 2011-08-29
K111608 SLIC SCREW REPAIR SYSTEM Acumed, LLC HWC Class II 2011-08-29
K111301 INSTINCT JAVA SYSTEM Zimmer Spine NKB Class II 2011-08-26
K110733 DAYTONA ANTERIOR CERVICAL CAGE Spinenet, LLC ODP Class II 2011-08-25
K111439 CHESAPEAKE (CERVICAL COMPONENTS) K2m, Inc. OVE Class II 2011-08-24
K111528 PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES Pioneer Surgical Technology, Inc. KWQ Class II 2011-08-24
K111525 PERIMETER INTERBODY FUSION DEVICE Medtronic Sofamor Danek MAX Class II 2011-08-24
K111620 SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS Skeletal Dynamics, LLC HRS Class II 2011-08-23
K102406 PASS ANTERIOR SPINAL SYSTEM Medicrea Technologies KWQ Class II 2011-08-23
K111502 STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc. NKB Class II 2011-08-23
K111352 TALON DISTALFIX PROXIMAL FEMORAL NAIL Orthopedic Designs North America, Inc. HSB Class II 2011-08-22
K111550 SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) Sonoma Orthopedic Products, Inc. HSB Class II 2011-08-19
K110879 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR Biomet Sports Medicine MBI Class II 2011-08-19
K111661 ARTHREX SCAPHOLUNATE ANCHOR Arthrex, Inc. MBI Class II 2011-08-19
K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-08-19
K111957 POLARIS SPINAL SYSTEM Biomet Spine (Ebi, LLC) NKB Class II 2011-08-19
K112108 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNI Class II 2011-08-19
K111698 PROFEMUR(R) E CEMENTLESS HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-08-19
K102785 TRIMED RADIOCARPAL FUSION SYSTEM TriMed, Inc. HRS Class II 2011-08-19
K111432 EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS Wrightmedicaltechnologyinc HRS Class II 2011-08-19
K102315 STAXX XDL SYSTEM Spine Wave, Inc. MQP Class II 2011-08-19

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