510(k) Report

Devices descending from K121683

682 later devices reach Acculif TL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K201671A-Link ZAcuity Surgical Devices, LLC202125—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+8K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K192993Scarlet AL-TSpineart20201—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K191134IB3D AlifMedicrea International SA20191—
+8K1803473d CageFims Co., Ltd.20190—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433