510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+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—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+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—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+9K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+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—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+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—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K183064TxTi IBF SystemInnovasis, Inc.2019481
+9K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+9K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+9K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+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—
+9K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—