510(k) Report

Devices descending from K012254

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K1803473d CageFims Co., Ltd.20190—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190488ProLift Expandable SystemLife Spine, Inc.201916—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181818Scarlet AL-TSpineart201864—
+6K181397DualXInnovasive, Inc.201815—
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181203Juliet TiSpineart20181—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—