510(k) Report

Devices descending from K090899

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+3K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+3K123231Caliber SpacersGlobus Medical, Inc.2013657—
+3K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+3K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+3K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+3K120101Independence SpacerGlobus Medical, Inc.2012224—
+3K113447Rise SpacerGlobus Medical, Inc.2012691—
+3K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+3K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+3K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K234150Lucent® XPSpinal Elements20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+4K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+4K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—