510(k) Report

Devices descending from K170962

304 later devices reach NuVasive® CoRoent® Thoracolumbar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+1K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+1K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+1K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+1K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+1K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+1K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+1K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+1K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+1K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K261049Scala® TLSpineart SA20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+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—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+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—
+2K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+2K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K261408SABER-XA SystemElevation Spine20260—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+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—
+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—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+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—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+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—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K240442MagnetOs PuttyKuros Biosciences B.V20243—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K240458Synthetic Bone PuttyVentris Medical20242—
+3K240459Cerament Bone Void FillerBonesupport AB20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232347MagnetOs GranulesKuros Biosciences B.V20242—
+3K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+3K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+3K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+3K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K232315Catalyst Bone Void FillerOssdsign AB20237—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—