510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+5K193174Keos Lumbar IBFDKeos20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+5K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K160125Cascadia Interbody SystemK2m2016315—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K152304Tritanium PL CageStryker20154481
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K140734Nextgen Altius Oct SystemEbi, LLC20140—
+5K141135Juliet LLSpineart2014146—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K131449Coalition SpacerGlobus Medical, Inc.2013235—
+5K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+5K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271