510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K141187Impix Alif S/aMedicrea International SA201501
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K142277Juliet POSpineart2014119—
+4K140280ForticoreNanovis, LLC20149—
+4K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+4K140303Alamo TAlliance Partners, LLC20140—
+4K140474Juliet OLSpineart2014120—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K133192Mectalif TipeekMedacta International201416—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+4K131178Idys Lif CagesClariance201311—
+4K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+4K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+4K120869Anchor-L Lumbar CageStryker Spine2012638—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+4K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+4K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+4K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+4K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+4K121116Plateau Spacer SystemLife Spine201213—
+4K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+4K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+4K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+4K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+4K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+4K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+4K103369Vault Alif SystemSpinal USA201110—
+4K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+4K093093Small Plateau Spacer SystemLife Spine2010393—
+4K101301Stalif MidlineCentinel Spine2010474—
+4K100889Endoskeleton TCTitan Spine, LLC2010455—
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K083475Lucent MagnumSpinal Elements, Inc.2009834—
+4K081711Lucent Magnum+Spinal Elements, Inc.20080—
+5K261049Scala® TLSpineart SA20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—