510(k) Report

Devices descending from K043566

726 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191134IB3D AlifMedicrea International SA20191—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171312FortiCore®Nanovis, LLC20183—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K240458Synthetic Bone PuttyVentris Medical20242—