510(k) Report

Devices descending from K132601

596 later devices reach Coroent Sterile Implants System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K141896Coroent SystemNu Vasive, Incorporated2014480—
+1K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+1K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+1K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+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—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+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—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+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—
+3K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+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—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+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—
+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—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+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—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181397DualXInnovasive, Inc.201815—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—