510(k) Report

Devices descending from K140319

590 later devices reach Coroent TI-C System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+1K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+1K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+1K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+1K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+1K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+1K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+2K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+2K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+2K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+2K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+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—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K261049Scala® TLSpineart SA20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+3K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+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—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+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—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+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—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232315Catalyst Bone Void FillerOssdsign AB20237—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+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—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—