510(k) Report

Devices descending from K082128

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140411Altera SpacerGlobus Medical, Inc.201419122
+4K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+4K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+4K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+4K123231Caliber SpacersGlobus Medical, Inc.2013657—
+4K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+4K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+4K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+4K120101Independence SpacerGlobus Medical, Inc.2012224—
+4K113447Rise SpacerGlobus Medical, Inc.2012691—
+4K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+4K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+4K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K242303MOD-COrthomod, LLC20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+5K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—