510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—