510(k) Report

Devices descending from K081614

843 later devices reach Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K153621Juliet® TiSpineart2016751
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K133192Mectalif TipeekMedacta International201416—
+6K261049Scala® TLSpineart SA20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—