510(k) Report

Devices descending from K041556

1,002 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223326Axiom PSR SystemRestor3D202301
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+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—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+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—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+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—
+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—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+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—
+8K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—