510(k) Report

Devices descending from K043566

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+8K223326Axiom PSR SystemRestor3D202301
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212562Idys-C ZP 3DTiClariance, SA20211—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—