510(k) Report

Devices descending from K082128

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+5K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200312Tryptik TiSpineart20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181397DualXInnovasive, Inc.201815—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—