510(k) Report

Devices descending from K030601

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+9K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+9K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K230614Cortium™Ulrich Medical USA20230—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K230026SqualeImplanet, S.A.20230—
+9K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+9K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+9K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+9K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K210359Hexanium TLIFSpinevision, S.A.S.20211—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+9K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+9K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+9K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+9K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+9K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—