510(k) Report

Devices descending from K040422

1,002 later devices reach Modification to Verte-Stack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+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—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223326Axiom PSR SystemRestor3D202301
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+9K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+9K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+9K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200316UNiD IB3D ALIFMedicrea International SA20200—
+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—
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+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—
+9K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+9K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+9K172816TiGer Shark™ SystemChoicespine, LP201859—