510(k) Report

Devices descending from K041197

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+8K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+8K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K192993Scarlet AL-TSpineart20201—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+8K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+8K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+8K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+8K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+8K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K151974Polaris Spinal SystemBiomet Spine201516—
+8K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+8K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+8K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+8K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—