510(k) Report

Devices descending from K080537

958 later devices reach L-Varlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+1K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+1K171519FLXfit™Expanding Orthopedics, Inc.2017711
+1K153786Prow Fusion-VNlt Spine, Ltd.20166—
+1K153400ProLift Expandable SystemLife Spine, Inc.201672—
+1K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+1K123231Caliber SpacersGlobus Medical, Inc.2013657—
+1K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+1K102293Caliber SpacerGlobus Medical, Inc.2011869—
+1K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+2K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K234150Lucent® XPSpinal Elements20240—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+2K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+2K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+2K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181397DualXInnovasive, Inc.201815—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K171425Concorde LiftMedos International SARL201782
+2K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+2K140280ForticoreNanovis, LLC20149—
+2K140411Altera SpacerGlobus Medical, Inc.201419122
+2K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+2K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+2K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+2K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+2K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+2K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K113447Rise SpacerGlobus Medical, Inc.2012691—
+2K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+2K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+3K261049Scala® TLSpineart SA20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—