meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2015-02-19

Clearances · page 58 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K142996 StaXx(R) XD System Spine Wave, Inc. MQP Class II 2015-02-19
K143049 LYNC intramedullary implant Novastep HTY Class II 2015-02-19
K141798 SYPHER SPACER SYSTEM Biogennix, LLC OVD Class II 2015-02-19
K140913 NUROS BONE GRAFT SUBSTITUTE Oriental Resources Development Limited MQV Class II 2015-02-17
K150105 Klassic Knee System-Sombrero Patella Total Joint Orthopedics, Inc. JWH Class II 2015-02-17
K143375 CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-02-13
K140881 DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS Depuy(Ireland) MBH Class II 2015-02-13
K143377 PedFuse Pedicle Screw System Spinefrontier, Inc. MNH Class II 2015-02-12
K141222 NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM Life Spine, Inc. NKB Class II 2015-02-12
K143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) Zimmer Spine, Inc. MAX Class II 2015-02-12
K143569 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-02-12
K143192 Vanguard 360 Revision Knee System Biomet, Inc. JWH Class II 2015-02-12
K143226 Visionaire Disposable Instruments Smith & Nephew, Inc. JWH Class II 2015-02-12
K140900 PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT Stanmore Worldwide Implants , Ltd. KRO Class II 2015-02-12
K150178 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-02-11
K143092 Tensyn Plug Dallen Medical, Inc. HTN Class II 2015-02-11
K150092 STERISPINE PS Pedicle Screw Safe Orthopaedics NKB Class II 2015-02-10
K150049 PASS LP Spinal System Medicrea International MNI Class II 2015-02-10
K142882 G7 Freedom and Offset Liners, Freedom Head, Size 32 Biomet, Inc. LPH Class II 2015-02-10
K150073 MICRONAIL Distal Radius System Wrightmedicaltechnologyinc HSB Class II 2015-02-10
K142451 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System Merete Medical GmbH HSB Class II 2015-02-09
K150062 Excia Total Hip System Aesculap Implant Systems, LLC LZO Class II 2015-02-09
K143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach Stryker Orthopaedics LPH Class II 2015-02-09
K143126 Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies MAX Class II 2015-02-06
K150028 Zimmer Segmental System XT Components Zimmer, Inc. KRO Class II 2015-02-06
K143229 Nexis osteosynthesis compressive screws Novastep HWC Class II 2015-02-06
K143618 Kirschner Wires, Steinmann Pins Zimmer, Inc. HTY Class II 2015-02-06
K143146 Nexis osteosynthesis snap-off screws Novastep HWC Class II 2015-02-06
K143471 VERTEX Reconstruction System Medtronic Sofamor Danek USA, Inc. NKG Class II 2015-02-06
K143276 Acumed Small Bone IM Nail System Acumed, LLC HSB Class II 2015-02-05
K143402 Extremity Medical Calcaneal Osteotomy Device Extremity Medical, LLC HWC Class II 2015-02-04
K143172 ACL SMART System Smith & Nephew, Inc. MAI Class II 2015-02-04
K143200 MIS Z-Pedicle Screw System Z-Medical GmbH & Co. KG NKB Class II 2015-02-03
K143543 Prelude PF Patellae Biomet, Inc. KRR Class II 2015-01-30
K143633 CREO Stabilization System Globus Medical, Inc. NKB Class II 2015-01-30
K143179 The LINK® Endo-Model® Knee System Waldemar Link GmbH & Co. KG KRO Class II 2015-01-30
K141548 HIGH TIBIAL OSTEOTOMY SYSTEM Newclip Technics HRS Class II 2015-01-30
K142957 Ideal pedicle screw spinal system Jiangsu Ideal Medical Science & Technology Co., Ltd. MNH Class II 2015-01-30
K141189 NANOBONE / GRANULATE Artoss GmbH MQV Class II 2015-01-30
K142940 Endoskeleton TCS System Titan Spine, LLC OVE Class II 2015-01-28
K143113 Klassic BiPolar System Total Joint Orthopedics KWY Class II 2015-01-28
K143509 MasterSL femoral stem Lima Corporate S.P.A. LZO Class II 2015-01-27
K143063 Stryker SonicPin System, Stryker SonicAnchor System Stryker Trauma GmbH HTY Class II 2015-01-27
K142201 OMNI Interface Acetabular System Omnlife Science LPH Class II 2015-01-26
K142237 Aviator Anterior Cervical Plate (ACP) System Stryker Corporation KWQ Class II 2015-01-26
K142655 CB PROT II Posterior Spinal System Chin Bone Technique Corp MNH Class II 2015-01-26
K143490 VERTA Corpectomy Cage Camber Spine MQP Class II 2015-01-26
K143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System Stryker Corporation OVD Class II 2015-01-26
K142606 Trident® Tritanium® PST® Acetabular Shells Mako Surgical Corp. LPH Class II 2015-01-26
K141980 LEVA (TM) SPACER SYSTEM Spine Wave, Inc. MAX Class II 2015-01-26
K143061 Activ Ankle Locking Plating System Newclip Technics HRS Class II 2015-01-26
K142030 STGC-LORDOTIC Cardinal Spine, LLC MQP Class II 2015-01-23
K143394 Acumed Small Fragment Base Set Acumed, LLC HRS Class II 2015-01-23
K143392 Quattro Bolt Tenodesis Screw Cayenne Medical, Inc. MBI Class II 2015-01-23
K141830 STIMULAN KIT, STIMULAN RAPID CURE Biocomposites, Ltd. MQV Class II 2015-01-23
K143460 Cannulated Screw System Wrightmedicaltechnologyinc HWC Class II 2015-01-23
K140547 EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM Excera Orthopedics, Inc. LPH Class II 2015-01-22
K142945 Sonoma Fibula Repair System Sonoma Orthopedic Products, Inc. HSB Class II 2015-01-22
K141599 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM Medtronic Sofamor Danek USA, Inc. OVE Class II 2015-01-21
K142360 Everest Spinal System K2m, Inc. NKB Class II 2015-01-21
K143366 ADVANCE Porous Coated Spiked Tibial Base Microport Orthopedics, Inc. MBH Class II 2015-01-21
K143065 NuVasive ALIF Buttress Plate System Nu Vasive, Incorporated KWQ Class II 2015-01-21
K142104 NANOFUSE DBM Nanotherapeutics, Inc. MQV Class II 2015-01-21
K143037 SnapShot Fixation System Biomet Manufacturing Corp JDR Class II 2015-01-20
K140898 PATIENT SPECIFIC DISTAL FEMORAL Stanmore Implants Worldwide , Ltd. KRO Class II 2015-01-20
K142838 Synapse Occipital-Cervical-Thoracic (OCT) System Synthes USA Products, LLC NKG Class II 2015-01-20
K143006 GUARDIAN-SG Inflatable Bone Expander System Bm Korea Co., Ltd. NDN Class II 2015-01-16
K143039 CrossRoads Screw System Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem HWC Class II 2015-01-16
K143614 Arthrex Low Profile Screws Arthrex, Inc. HWC Class II 2015-01-16
K143139 Arthrex Fracture System Arthrex, Inc. HRS Class II 2015-01-16
K142599 PRECISE Trauma Nail System Ellipse Technologies, Incorporated HSB Class II 2015-01-16
K143023 Nitinol Compression Plating System Biomedical Enterprises, Inc. HRS Class II 2015-01-16
K142276 MCS Bone Graft Biostructures, LLC MQV Class II 2015-01-16
K141187 IMPIX ALIF S/A Medicrea International SA OVD Class II 2015-01-15
K142828 osteoSPAN Morpheus Biogennix MQV Class II 2015-01-15
K142741 OASYS System Stryker Corporation KWP Class II 2015-01-15
K142675 CI../..X liner for NOVAE Dual Mobility Acetabular Cup Serf LZO Class II 2015-01-15
K141549 SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. OUR Class II 2015-01-15
K143549 Vivorte Trabexus Vivorte, Inc. MQV Class II 2015-01-14
K143547 Vivorte Trabexus EB Vivorte, Inc. MBP Class II 2015-01-14
K142057 INFIX CANNULATED SCREW SYSTEM Infix Medical, LLC HWC Class II 2015-01-13
K143393 Triathlon Tritanium Cone Augments Stryker Orthopaedics MBH Class II 2015-01-13
K143624 Headless Compression Screw System Skeletal Dynamics, LLC HWC Class II 2015-01-13
K142939 Revolution Spinal Fixation System Intelligent Implant Systems, LLC NKB Class II 2015-01-13
K142948 BIOSURE REGENESORB interference Screw Smith & Nephew, Inc. MAI Class II 2015-01-13
K141398 PASS LP SPINAL SYSTEM Medicrea International SA NKB Class II 2015-01-09
K140046 SPINOUS PROCESS FUSION (SPF) PLATE Spinal Simplicity, LLC PEK Class II 2015-01-09
K141253 NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM New Era Orthopaedics, LLC MNI Class II 2015-01-09
K143334 Range/Denali/Mesa Spinal System K2m, Inc. NKB Class II 2015-01-09
K142152 CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM Orthofix, Inc. ODP Class II 2015-01-08
K143220 SIDEKICK EZ FRAME External Fixation System Wrightmedicaltechnologyinc KTT Class II 2015-01-08
K141857 CrossTie Intraosseous Fixation System Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem HWC Class II 2015-01-08
K140359 MAXIMIS SPINAL FIXATION SYSTEM Valorem Surgical MNH Class II 2015-01-07
K143149 Arsenal Spinal Fixation System Alphatec Spine, Inc. NKB Class II 2015-01-05
K141186 FIREBIRD SPINAL FIXATION SYSTEM Orthofix, Inc. NKB Class II 2015-01-02
K142699 LITe Plate System Stryker Corporation KWQ Class II 2014-12-31
K141695 ACROSSPINE PEDICLE SCREW SYSTEM Arthro-Dif NKB Class II 2014-12-30
K143188 3.Omm Biomet Cannulated Screw System Biomet Manufacturing Corp HWC Class II 2014-12-30
K142746 G7 Finned Acetabular Shell Biomet Manufactuting Corp. LPH Class II 2014-12-29
K140649 VECTRIX EXTERNAL FIXATOR 3D Medical Concepts, LLC NDK Class II 2014-12-29

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