510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+4K151654Prow FusionNlt Spine, Ltd.20151—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K141135Juliet LLSpineart2014146—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+4K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—