510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K142277Juliet POSpineart2014119—
+5K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140474Juliet OLSpineart2014120—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K133192Mectalif TipeekMedacta International201416—
+5K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+5K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133126K7 Lumbar SpacersK7, LLC20131—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K130853Idys (TM) CClariance20132—
+5K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124034Mectalif AnteriorMedacta International201311—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123969XiphosDifusion Technologies201314—
+5K122592Instinct Java SystemZimmer Spine201301
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+5K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K122444Cervical CageEisertech, LLC201222—
+5K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+5K121176STGCCardinal Spine, LLC201259—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—