510(k) Report

Devices descending from K141665

588 later devices reach NuVasive CoRoent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+1K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+1K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+1K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+1K172009Cascadia Interbody SystemK2m, Inc.2017433
+1K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+1K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+1K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+1K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+1K153786Prow Fusion-VNlt Spine, Ltd.20166—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+1K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+1K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+1K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+1K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+1K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K261049Scala® TLSpineart SA20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+2K221172FOCUS Interbody SystemOc Medical Devices20220—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+2K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+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—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+2K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+2K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181397DualXInnovasive, Inc.201815—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+2K162496Foundation 3D InterbodyCorelink, LLC201782—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+2K143479Bluefin Interbody SystemTides Medical20152—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—