510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+10K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223251Hexanium PLIFSpinevision, S.A.S.20220—
+10K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+10K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+10K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+10K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+10K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+10K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+10K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+10K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+10K200896Solstice CCILife Spine, Inc.20200—
+10K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001
+10K1803473d CageFims Co., Ltd.20190—
+10K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+10K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+10K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+10K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+10K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+10K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+10K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+10K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+10K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+10K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+10K161149PASS OCT Spinal SystemMedicrea International SA20160—
+10K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+10K160756PASS OCT Spinal SystemMedicrea International SA20160—
+10K153169PASS OCT Patient Specific RodsMedicrea International20164—
+10K152211PCT SystemCentinel Spine, Inc.20150—
+10K151974Polaris Spinal SystemBiomet Spine201516—
+10K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+10K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+10K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+10K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+10K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+10K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+10K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+11K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+11K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+11K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+11K253545Vulcan Spinal SystemK2m, Inc.20260—
+11K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+11K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+11K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+11K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+11K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+11K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+11K200303Reform Pedicle Screw SystemPrecision Spine202010—
+11K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+11K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+11K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+11K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+11K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+11K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+11K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+11K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+11K180433Ennovate®Aesculap Implant Systems, LLC201811
+11K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+11K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+11K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—