510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+6K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+6K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+6K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K133192Mectalif TipeekMedacta International201416—
+6K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+6K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+6K133126K7 Lumbar SpacersK7, LLC20131—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+6K130853Idys (TM) CClariance20132—
+6K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+6K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+6K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+6K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K131077Life Spine Plateau Spacer SystemLife Spine201310—
+6K121178Transcorp Acif SystemTranscorp, Inc.20130—
+6K131372Mobis IISignus Medizintechnik GmbH2013462—
+6K122588Vusion CS PlusOrtho Development Corp.2013206—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K122877Range Spinal System, Small StatureK2m, Inc.201334—
+6K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+6K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K122592Instinct Java SystemZimmer Spine201301
+6K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+6K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+6K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+6K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+6K120401Alamo TAlliance Partners, LLC20121—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+6K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+6K121630Range Spinal SystemK2m, Inc.2012127—
+6K122444Cervical CageEisertech, LLC201222—
+6K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+6K121176STGCCardinal Spine, LLC201259—
+6K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+6K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+6K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+6K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+6K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+6K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+6K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+6K120928Synthes Matrix SystemSynthes Spine20120—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+6K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K120576Zavation Ibf SystemZavation, LLC201232—
+6K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+6K113478Plif CageEisertech, LLC2012269—
+6K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+6K113138Aleutian SystemK2m, Inc.2012549—
+6K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+6K112664Zavation Ibf SystemsZavation, LLC201137—
+6K112862Mecta-CMedacta International201114—
+6K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+6K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+6K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+6K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+6K111484DiscoveryIntuitive Spine, LLC20111—
+6K102315Staxx XDL SystemSpine Wave, Inc.20113—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K110915Cervical CageEisertech, LLC201123—
+6K111469Staxxsd SystemSpine Wave, Inc.20110—
+6K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+6K110177Helena SystemRoyal Oak Medical Devices20110—
+6K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121