510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K192897icotec Cervical CageIcotec AG20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K193174Keos Lumbar IBFDKeos20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K173893TrabisColigne AG20180—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171312FortiCore®Nanovis, LLC20183—