510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K200312Tryptik TiSpineart20202—
+4K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192993Scarlet AL-TSpineart20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181818Scarlet AL-TSpineart201864—