510(k) Report

Devices descending from K082128

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+1K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+1K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K190284Bengal Stackable Cage SystemMedos International SARL20190—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K170235Lucent®Spinal Elements, Inc.2017107—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+2K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+2K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+3K123913Latis SpacerGlobus Medical, Inc.201388—
+3K122097Patriot SpacersGlobus Medical, Inc.2012261—
+3K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+3K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+3K102293Caliber SpacerGlobus Medical, Inc.2011869—
+3K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+3K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K234150Lucent® XPSpinal Elements20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—