510(k) Report

Devices descending from K093242

921 later devices reach Patriot Transcontinental Llif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+1K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K123913Latis SpacerGlobus Medical, Inc.201388—
+1K122097Patriot SpacersGlobus Medical, Inc.2012261—
+1K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+1K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+1K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+1K102293Caliber SpacerGlobus Medical, Inc.2011869—
+1K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+2K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+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—
+2K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+2K133717Longbow Spacer SystemLife Spine20149—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K140411Altera SpacerGlobus Medical, Inc.201419122
+2K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+2K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+2K130461Stalif XCentinel Spine, Inc.201313—
+2K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+2K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+2K123231Caliber SpacersGlobus Medical, Inc.2013657—
+2K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+2K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+2K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+2K120101Independence SpacerGlobus Medical, Inc.2012224—
+2K113447Rise SpacerGlobus Medical, Inc.2012691—
+2K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+2K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+2K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—