510(k) Report

Devices descending from K023570

1,383 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K192993Scarlet AL-TSpineart20201—
+6K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K193174Keos Lumbar IBFDKeos20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K192117Small VBR™Ulrich GmbH & Co. KG20196—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K1803473d CageFims Co., Ltd.20190—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172424Velofix™ SA Cervical CageU&I Corporation201751
+6K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—