510(k) Report

Devices descending from K141896

480 later devices reach Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+1K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+2K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+2K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+2K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K143479Bluefin Interbody SystemTides Medical20152—
+3K261049Scala® TLSpineart SA20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+3K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+3K192993Scarlet AL-TSpineart20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+3K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K261408SABER-XA SystemElevation Spine20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—