510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+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—
+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—
+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—
+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—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+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—
+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—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+7K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K173128Alamo® CAlliance Partners, LLC20182—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—