510(k) Report

Devices descending from K031780

1,326 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K234150Lucent® XPSpinal Elements20240—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K230026SqualeImplanet, S.A.20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+7K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—