510(k) Report

Devices descending from K023835

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K140411Altera SpacerGlobus Medical, Inc.201419122
+5K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+5K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+5K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K123231Caliber SpacersGlobus Medical, Inc.2013657—
+5K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+5K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+5K120101Independence SpacerGlobus Medical, Inc.2012224—
+5K113447Rise SpacerGlobus Medical, Inc.2012691—
+5K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+5K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+5K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—