meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2014-04-17

Clearances · page 63 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133270 SPEED ARC Biomedical Enterprises, Inc. JDR Class II 2014-04-17
K140397 PARALOCK PLATING SYSTEM / TUFFNEK SCREW Paragon 28 HRS Class II 2014-04-17
K133802 AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. MQP Class II 2014-04-17
K133815 INTESS CERVICAL CAGE SYSTEM Kalitec Direct, LLC ODP Class II 2014-04-16
K132620 INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL Pan Medical , Ltd. NDN Class II 2014-04-16
K132738 COGENT MED-LIF Cogent Spine, LLC MAX Class II 2014-04-15
K140219 PICASSO II MIS SPINAL SYSTEM Accel Spine NKB Class II 2014-04-14
K132999 CERVICAL STAND ALONE SYSTEM Orthofix, Inc. OVE Class II 2014-04-14
K130778 DISCOSCOPES, CERVICAL ENDOSCOPES Rz Medizintechnik GmbH HRX Class II 2014-04-14
K132312 RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM Renovis Surgical Technologies, LLC LPH Class II 2014-04-11
K132596 PROPOSED OPTIMUS Custom Spine, Inc. OVD Class II 2014-04-11
K133340 SPINEWORKS ANTERIOR LUMBAR DEVICE Spineworks, LLC MAX Class II 2014-04-11
K140645 GIBRALT ROD-TO-ROD CROSS CONNECTORS Exactech Sarasota KWP Class II 2014-04-11
K133932 INION FREEDOMPIN Inion OY HTY Class II 2014-04-11
K132290 SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES Materialise NV PBF Class II 2014-04-10
K140696 STREAMLINE TL SPINAL FIXATION SYSTEM Pioneer Surgical Technology, Inc. NKB Class II 2014-04-10
K130531 ULTRAFUSE Baxter Healthcare Corp MQV Class II 2014-04-08
K133366 ORTHROS POSTERIOR STABILIZATION SYSTEM Camber Spine NKB Class II 2014-04-08
K140007 ABACUS TM SPACER SYSTEM Spine Wave, Inc. MAX Class II 2014-04-07
K140069 LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 Merete Medical GmbH HRS Class II 2014-04-07
K133235 THREADED PEEK K-WIRE Mtp Solutions, LLC MBI Class II 2014-04-07
K133743 BAXANO SURGICAL MIS SPINAL SYSTEM Baxano Surgical, Inc. NKB Class II 2014-04-07
K133844 SPEED TRIAD Biomedical Ent., Inc. JDR Class II 2014-04-07
K140372 FRAGMENT PLATE SYSTEM Skeletal Dynamics, LLC HRS Class II 2014-04-07
K132911 I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW In2bones Sas HWC Class II 2014-04-04
K140018 TSP HIP FRACTURE PLATING SYSTEM Biomet, Inc. JDO Class II 2014-04-04
K133777 TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR Tornier, Inc. MBI Class II 2014-04-04
K133669 MEDINAUT KYPHOPLASTY SYSTEM Imedicom NDN Class II 2014-04-04
K140376 VARIAX 2 SYSTEM Stryker Trauma AG HRS Class II 2014-04-03
K140003 COROENT SMALL INTERBODY SYSTEM Nuvasive, Inc. ODP Class II 2014-04-03
K133834 DEPUY GLOBAL UNITE SHOULDER SYSTEM Depuy(Ireland) KWS Class II 2014-04-03
K133614 ALEUTIAN IBF SYSTEM K2m, Inc. MAX Class II 2014-04-03
K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD Microport Orthopedics, Inc. LZO Class II 2014-04-03
K132483 INNESIS PEEK CERVICAL CAGE Bk Meditech, Co., Ltd. ODP Class II 2014-04-02
K140257 SIGNATURE PLANNER, SIGNATURE GUIDES Materialise NV MBH Class II 2014-04-02
K133939 MODIFIED DISTAL RADIUS PLATING SYSTEM Biomet HRS Class II 2014-04-01
K133606 N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL ArthroCare Corporation MBI Class II 2014-04-01
K140259 VARIAX CLAVICLE HOOK PLATE Stryker Trauma AG HRS Class II 2014-04-01
K140414 IMBIBE NEEDLE Orthovita, Inc. LXH Class I 2014-04-01
K131984 SYNTHES SYNSONIC ULNA NAIL Synthes (Usa) HSB Class II 2014-03-31
K133721 INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 Pinnacle Spine Group, LLC MAX Class II 2014-03-31
K133940 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) Biomet UK, Ltd. HRY Class II 2014-03-28
K133560 ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM Conformis, Inc. JWH Class II 2014-03-28
K133515 PEEK FUSION IMPLANT Mtp Solutions, LLC HWC Class II 2014-03-28
K133636 EXTREMITY MEDICAL HAMMERTOE DEVICE Extremity Medical, LLC HWC Class II 2014-03-28
K132572 I-HIP TOTAL HIP SYSTEM Iconacy Orthopedic Implants, LLC LPH Class II 2014-03-28
K133455 CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC Pioneer Surgical Technology, Inc. MAX Class II 2014-03-27
K133930 FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET Flower Orthopedics Corporation HRS Class II 2014-03-27
K140106 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. OVD Class II 2014-03-27
K140452 VEGA KNEE SYSTEM Aesculap Implant Systems JWH Class II 2014-03-25
K140457 NAUTILUS SPINAL SYSTEM Life Spine, Inc. NKB Class II 2014-03-25
K140079 SILEX SACROILIAC JOINT FUSION SYSTEM X-Spine Systems, Inc. OUR Class II 2014-03-25
K140449 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2014-03-25
K130550 RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW Encore Medical L.P. PHX Class II 2014-03-24
K132656 PRODENSE BONE GRAFT SUBSTITUTE Wrightmedicaltechnologyinc MQV Class II 2014-03-24
K132250 INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM Integra LifeSciences Corporation JWJ Class II 2014-03-24
K133974 VARIAX DISTAL RADIUS PLATING SYSTEM Stryker Leibinger GmbH HRS Class II 2014-03-24
K133944 RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM K2m, Inc. NKB Class II 2014-03-21
K133842 TYBER MEDICAL TRAUMA SCREW Tyber Medical, LLC HWC Class II 2014-03-20
K133529 CAMBER SPINE COVERIS CERVICAL CAGE Camber Spine ODP Class II 2014-03-20
K134038 CAMBER SPINE DIAGON OBLIQUE CAGE Camber Spine MAX Class II 2014-03-20
K133374 STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM Pioneer Surgical Technology, Inc. (Rti Surgical, I KWP Class II 2014-03-19
K132078 METALLIC INTRAMEDULLARY NAIL SYSTEM Tianjin Walkman Biomaterial Co., Ltd. HSB Class II 2014-03-19
K133780 SPEED XL Biomedical Ent., Inc. JDR Class II 2014-03-19
K133893 STERISPINE LC CAGE Safe Orthopaedics MAX Class II 2014-03-14
K132805 BG MORSELS Prosidyan, Inc. MQV Class II 2014-03-14
K132752 ULTRACONGRUENT INSERT United Orthopedic Corporation JWH Class II 2014-03-13
K133205 CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2014-03-13
K140276 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek OSH Class II 2014-03-13
K133832 KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS Total Joint Orthopedics, Inc. LPH Class II 2014-03-13
K133221 ARSENAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. NKB Class II 2014-03-13
K133381 OMNI ARC MONOBLOCK HIP STEM Omnilife Science LZO Class II 2014-03-13
K140107 EMERGE MEDICAL DISTAL RADIUS SET Emerge Medical HRS Class II 2014-03-13
K133746 POLARIS SPINAL SYSTEM Biomet Spine (Aka Ebi, LLC) NKB Class II 2014-03-12
K140119 EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM Emerge Medical HRS Class II 2014-03-12
K140098 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM Emerge Medical HRS Class II 2014-03-12
K133386 OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM Ortho Development Corp. LPH Class II 2014-03-11
K133350 REVERE STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2014-03-11
K133104 VAN HIP FRACTURE SYSTEM Epix Orthopaedic, Corp. HSB Class II 2014-03-10
K133469 ACUMED SUTURE ANCHOR SYSTEM Acumed, LLC MBI Class II 2014-03-10
K132959 DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. LPH Class II 2014-03-10
K140328 CMC MINI TIGHTROPE Arthrex, Inc. HTN Class II 2014-03-10
K140148 PRO-TOE HAMMERTOE FIXATION SYSTEM Wrightmedicaltechnologyinc HWC Class II 2014-03-07
K133363 INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM Ldr Spine USA, Inc. PEK Class II 2014-03-07
K133713 CHARLOTTE (TM) SNAP-OFF SCREW Wrightmedicaltechnologyinc HWC Class II 2014-03-07
K133214 BLACKBIRD SPINAL SYSTEM Choicespine, LP KWP Class II 2014-03-07
K132945 CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL I.T.S. GmbH HSB Class II 2014-03-07
K132244 N-FORCE FIXATION SYSTEM Innovision, Inc. HWC Class II 2014-03-06
K133036 APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS Amendia, Inc. MBI Class II 2014-03-06
K133459 ELITE IBF Innova Spinal Technologies, LLC MAX Class II 2014-03-06
K132926 VELOFIXTM INTERBODY FUSION SYSTEM U&I Corp. ODP Class II 2014-03-05
K133525 LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM Changzhou Dean Medical Instrument Co, Ltd. HRS Class II 2014-03-04
K133668 AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL Shoulder Options, Inc. HRS Class II 2014-03-03
K131548 SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM Synthes (USA) Products, LLC HSB Class II 2014-02-28
K140283 OSTEOMED EXTREMIFUSE SYSTEM Osteomed HWC Class II 2014-02-28
K133715 CHARLOTTE CLAW PLATE SYSTEM Wrightmedicaltechnologyinc HRS Class II 2014-02-28
K133671 ICONIX ALL SUTURE ANCHORS Stryker Corp. MBI Class II 2014-02-28
K133858 TENSYN BAND Dallen Medical, Inc. HTN Class II 2014-02-28
K133451 FIXOS SCREW SYSTEM Stryker Trauma AG HWC Class II 2014-02-28
K140178 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc. PGN Class II 2014-02-27

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