510(k) Report

Devices descending from K030735

816 later devices reach Modified 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—
+9K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+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—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+9K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+9K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+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—
+9K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+9K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+9K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K210359Hexanium TLIFSpinevision, S.A.S.20211—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+9K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+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—
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+9K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+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—
+9K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+9K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+9K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+9K183064TxTi IBF SystemInnovasis, Inc.2019481
+9K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+9K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+9K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—