meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2014-12-23

Clearances · page 59 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K142502 ALIANS ULNA LOCKING PLATING SYSTEM Newclip Technics HRS Class II 2014-12-23
K142328 nvc Nvision Biomedical Technologies, LLC ODP Class II 2014-12-23
K141920 Wrist Hemiarthroplasty System Arthrosurface, Inc. KWN Class II 2014-12-23
K143407 Klassic HD Hip System Total Joint Othopedics, Inc. LZO Class II 2014-12-23
K142933 Biomet Tibial trays Biomet, Inc. JWH Class II 2014-12-23
K142787 Zimmer Persona Personalized Knee System Zimmer, Inc. JWH Class II 2014-12-22
K143138 AxSOS 3 Ti Locking Plate System Stryker Trauma AG HRS Class II 2014-12-22
K142807 ANTHEM PS Total Knee System Smith & Nephew, Inc. JWH Class II 2014-12-22
K142528 AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm Agent Medical, LLC HWC Class II 2014-12-22
K142558 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2m KWP Class II 2014-12-22
K142111 ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE Novatsep JDR Class II 2014-12-19
K142041 POROSTEON PHUSION METAL CERVICAL CAGE Porosteon, Inc. ODP Class II 2014-12-19
K142271 Zavation Z-Link Lumbar Zavation, LLC OVD Class II 2014-12-19
K142707 AIS Odontoid Fracture Fixation System Aesculap Implant System, Inc. HWC Class II 2014-12-19
K142942 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System Arthrosurface, Inc. HSD Class II 2014-12-19
K143248 Reform Pedicle Screw System Precision Spine, Inc. NKB Class II 2014-12-19
K142463 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc. MQV Class II 2014-12-18
K141420 FASTFORWARD MedShape, Inc. HTN Class II 2014-12-18
K143403 Threshold Pedicular Fixation System Spineology, Inc. NKB Class II 2014-12-18
K140855 ARTHREX SUTURETAK SUTURE ANCHORS Arthrex, Inc. MAI Class II 2014-12-18
K142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene Seaspine, Inc. MAX Class II 2014-12-18
K143009 Echo Bi-Metric Microplasty Hip System Biomet, Inc. LPH Class II 2014-12-18
K143050 VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws Smith & Nephew, Inc. HRS Class II 2014-12-18
K142737 MAS PLIF Fixation system Nu Vasive, Incorporated NKB Class II 2014-12-18
K142378 Interspinous Plate System Precision Spine, Inc. PEK Class II 2014-12-18
K142419 Mini and Micro Fragments Reconstruction System-NEOFIX Neoortho Productos Orthopedicos S/A HRS Class II 2014-12-16
K142490 ProxiFuse Hammer Toe Device Cartiva, Inc. HWC Class II 2014-12-15
K142643 Stabilynx PEEK Suture Anchor D3 Dc, LLC /Stabilynx, Inc. MBI Class II 2014-12-15
K140734 NEXTGEN ALTIUS OCT SYSTEM Ebi, LLC KWP Class II 2014-12-15
K142146 IBIS PEDICLE SCREW SYSTEM Ortho Development Corp. NKB Class II 2014-12-11
K140669 G7 OSSEOTI ACETUBLAR SHELLS Biomet, Inc. LPH Class II 2014-12-11
K142404 iTotal Posterior Stabilized (PS) Knee Replacement System Conformis, Inc. JWH Class II 2014-12-11
K133218 Crystal ®; Mosaic ®; Vertu ® Spinal Elements, Inc. OVE Class II 2014-12-10
K143125 Orthofix True Lok Hexapod System VI.3 Orthofix Srl KTT Class II 2014-12-10
K141557 HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR Gallini Medical Devices, Srl HRX Class II 2014-12-08
K141760 ORTHOFIX GALAXY WRIST Orthofix Srl KTT Class II 2014-12-08
K142264 Valeo C Spacer System, Valeo II C IBF Device Amedica Corp. ODP Class II 2014-12-08
K142388 Neo Total Knee System New Era Orthopedics, LLC JWH Class II 2014-12-05
K143025 TOTAL COMPRESSION PLATING SYSTEM Wrightmedicaltechnologyinc HRS Class II 2014-12-05
K142052 ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT Orthofix Srl KTT Class II 2014-12-05
K141632 ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek USA, Inc. KWQ Class II 2014-12-04
K142069 GMK EXTENSION Medacta International JWH Class II 2014-12-02
K141282 PGS 5.5 MM CANNULATED PEDICLE SCREW Pinnacle Spine Group NKB Class II 2014-12-02
K141135 JULIET LL Spineart MAX Class II 2014-12-01
K142591 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2014-12-01
K143141 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2014-12-01
K142594 nva, nvp, nvt Nvision Biomedical Technologies, LLC MAX Class II 2014-11-28
K143066 Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers Zimmer, Inc. HRS Class II 2014-11-28
K142938 G3 Active Plate Large Fragment System Genesis Fracture Care, Inc. HRS Class II 2014-11-26
K142863 Univers Rivers Shoulder Prosthesis System Arthrex, Inc. PHX Class II 2014-11-25
K141537 IN:C2 SPINAL FIXATION SYSTME Spine Smith Holdings, LLC OVE Class II 2014-11-25
K141333 ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. ODP Class II 2014-11-25
K142299 CoRoent Small Interlock System Nu Vasive, Incorporated OVE Class II 2014-11-25
K140716 OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE Interventional Spine, Inc. MAX Class II 2014-11-24
K142072 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) Custom Orthopaedic Solutions, Inc. KWS Class II 2014-11-24
K142403 Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System Zimmer GmbH KWS Class II 2014-11-24
K142290 KangLi pedical screw spinal system Suzhou Kangli Orthopaedics Instrument Co., Ltd. MNH Class II 2014-11-24
K143106 VEGA Knee System Aesculap Implant Systems, LLC JWH Class II 2014-11-21
K141377 BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD Merete Medical GmbH LZO Class II 2014-11-21
K142585 PhaLinx Hammertoe System Wrightmedicaltechnologyinc HWC Class II 2014-11-20
K142023 LUNA INTERBODY SYSTEM Benvenue Medical, Inc. MAX Class II 2014-11-20
K141896 COROENT SYSTEM Nu Vasive, Incorporated MAX Class II 2014-11-20
K142520 Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software Smith & Nephew, Inc. KTT Class II 2014-11-20
K143047 Arthrex iBalance Patella Implant, Dome Arthrex, Inc. JWH Class II 2014-11-19
K141263 TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS Biomet Manufacturing Corp JDR Class II 2014-11-19
K142251 AVS AS PEEK Spacer Stryker Corporation ODP Class II 2014-11-19
K142499 Reline System Nu Vasive, Incorporated NKB Class II 2014-11-19
K142185 EXPEDIUM VERSE SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2014-11-19
K130019 J-SCREW COMPRESSION SCREW Competitive Engineering, Inc. HWC Class II 2014-11-18
K142587 Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc. MDI Class II 2014-11-18
K142347 Amedica Valeo II Interbody Fusion Device Amedica Corp. MAX Class II 2014-11-18
K142060 TRANSOM ANTERIOR CERVICAL PLATE Neurostructures, Inc. KWQ Class II 2014-11-18
K141345 AEQUALIS FX2 Tornier S.A.S. PHX Class II 2014-11-18
K141317 ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine, Inc. PEK Class II 2014-11-17
K140222 SAIPH KNEE SYSTEM Matortho JWH Class II 2014-11-17
K133827 A-LINK Z Osteo Vasive, LLC OVD Class II 2014-11-17
K142292 Speed, Speed Shift, Speed Titan, Speed Arc Biomedical Enterprises, Inc. JDR Class II 2014-11-17
K142462 Restoration Anatomic Shell Stryker Orthopaedics LPH Class II 2014-11-14
K142161 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2014-11-14
K142413 TITAN Modular Total Shoulder System Ascension Orthopedics KWS Class II 2014-11-14
K141471 JOURNEY II XR KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2014-11-14
K142066 AERO-LL LUMBAR CAGE SYSTEM Stryker Corporation OVD Class II 2014-11-13
K142658 Biomet Headless Compression and Twist-off Screws Biomet Manufacturing Corp HWC Class II 2014-11-13
K141571 ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM Orthofix Srl HSB Class II 2014-11-12
K142836 Zimmer Plates and Screws (ZPS), Forte Screws Zimmer, Inc. HRS Class II 2014-11-12
K140961 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Trauma AG KTT Class II 2014-11-10
K142139 SMR 40MM GLENOSPHERE Lima Corporate S.P.A. PHX Class II 2014-11-07
K141990 ENCORE HUMERAL SHOULDER STEM Encore Medical L.P. PHX Class II 2014-11-07
K142550 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments Microport Orthopedics, Inc. JWH Class II 2014-11-07
K141942 MIDLINE II TI Centinel Spine, Inc. OVD Class II 2014-11-07
K133166 INS HILDEN TIBIAL ARZZT Truemed Group, LLC HSB Class II 2014-11-06
K141993 NAKOMA ACP Alliance Partners, LLC KWQ Class II 2014-11-06
K142187 LINK MP RECONSTRUCTION PROSTHESIS Waldemar Link GmbH & Co. KG LZO Class II 2014-11-06
K142016 CAPRI K2m, Inc. MQP Class II 2014-11-06
K140130 X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED Encore Medical L.P. OQG Class II 2014-11-06
K133518 MAXAN ANTERIOR CERVICAL PLATE SYSTEM Biomet Spine (Aka Ebi, LLC) KWQ Class II 2014-11-05
K141676 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc. LPH Class II 2014-11-04
K140738 PASS LP SPINAL SYSTEM Medicrea International MNI Class II 2014-11-04
K141207 NOVABONE BIOACTIVE STRIP Novabone Products, LLC MQV Class II 2014-10-31
K142484 Sternal Closure System Jace Medical, LLC HRS Class II 2014-10-31

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