510(k) Report

Devices descending from K161230

381 later devices reach NuVasive Lumbar Interbody Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+1K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+1K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+1K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+1K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+1K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+1K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+1K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+1K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+1K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+1K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+1K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+1K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+1K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K261049Scala® TLSpineart SA20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+2K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K192993Scarlet AL-TSpineart20201—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+2K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K261408SABER-XA SystemElevation Spine20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K250556Porous Biologic ScaffoldVentris Medical20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+3K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+3K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K240442MagnetOs PuttyKuros Biosciences B.V20243—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—