510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181203Juliet TiSpineart20181—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173508Everest Spinal SystemK2m20189—
+6K173702Juliet Ti LLSpineart20182—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K171425Concorde LiftMedos International SARL201782
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K162587Roccia® AcifSilony Medical GmbH20171—
+6K162262Tritanium® PL CageStryker2016132—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160955Tritanium® PL CageStryker2016178—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K142277Juliet POSpineart2014119—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K140474Juliet OLSpineart2014120—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K132559Monument SpacersGlobus Medical, Inc.2013166—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+6K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K123767Lanx Fusion System- SALanx, Inc.20133244
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+6K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—