510(k) Report

Devices descending from K113465

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140411Altera SpacerGlobus Medical, Inc.201419122
+1K130194Acculif XL CageCoalign Innovations, Inc.20131—
+1K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+1K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+1K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181397DualXInnovasive, Inc.201815—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K153400ProLift Expandable SystemLife Spine, Inc.201672—
+2K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+2K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+2K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+2K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+3K261049Scala® TLSpineart SA20260—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172756Varian cageMedyssey USA, Inc.20171—
+3K171519FLXfit™Expanding Orthopedics, Inc.2017711
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K141217Acculif TL and PL CageStryker Corporation20146423
+4K261408SABER-XA SystemElevation Spine20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—