510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K200919Idys ALIF 3DTiClariance20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K200429BEE CagesNGMedical GmbH202111—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192993Scarlet AL-TSpineart20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K190284Bengal Stackable Cage SystemMedos International SARL20190—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K193174Keos Lumbar IBFDKeos20190—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—