510(k) Report

Devices descending from K120918

642 later devices reach Nuvasive Coroent Titanium System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+1K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+1K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+1K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+1K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K141135Juliet LLSpineart2014146—
+1K141896Coroent SystemNu Vasive, Incorporated2014480—
+1K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+1K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+1K130630Plateau Spacer System TitaniumLife Spine, Inc.201317—
+1K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+2K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+2K173702Juliet Ti LLSpineart20182—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K261049Scala® TLSpineart SA20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+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—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+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—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—