510(k) Report

Devices descending from K062073

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—