510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K202380Born PT-LIF Cage HASpineworxx AG20210—
+6K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200312Tryptik TiSpineart20202—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190488ProLift Expandable SystemLife Spine, Inc.201916—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+6K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—