510(k) Report

Devices descending from K092193

647 later devices reach Spinal Usa Interbody Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210728CONDUIT InstrumentsMedos International SARL20215—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—