510(k) Report

Devices descending from K090899

932 later devices reach Depuy Spine Lateral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+1K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+2K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+2K123913Latis SpacerGlobus Medical, Inc.201388—
+2K122097Patriot SpacersGlobus Medical, Inc.2012261—
+2K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+2K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+2K102293Caliber SpacerGlobus Medical, Inc.2011869—
+2K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+2K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K230583Tryptik TiSpineart SA20231—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+3K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+3K140411Altera SpacerGlobus Medical, Inc.201419122
+3K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+3K133514Xcage Interbody Fusion SystemOuroboros Medical201415—