510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+7K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+7K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+7K172065Scarlet AC-TSpineart20172—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K171519FLXfit™Expanding Orthopedics, Inc.2017711
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+7K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162262Tritanium® PL CageStryker2016132—
+7K160955Tritanium® PL CageStryker2016178—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K160125Cascadia Interbody SystemK2m2016315—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+7K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K142487Chesapeake Stabilization SystemK2m, Inc.201571
+7K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+7K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+7K141217Acculif TL and PL CageStryker Corporation20146423
+7K130853Idys (TM) CClariance20132—
+7K131449Coalition SpacerGlobus Medical, Inc.2013235—
+7K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+7K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+7K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+7K112388Lanx Cervical SALanx, Inc.201126—
+7K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+7K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+7K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+7K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+7K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K242303MOD-COrthomod, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—