510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230026SqualeImplanet, S.A.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—