510(k) Report

Devices descending from K121683

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K171312FortiCore®Nanovis, LLC20183—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+7K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K261049Scala® TLSpineart SA20260—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240699SCARLET® AC-TiSpineart SA20240—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230583Tryptik TiSpineart SA20231—