510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K163589SIGN IM NailSign Fracture Care International20170—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+6K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+6K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+6K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151654Prow FusionNlt Spine, Ltd.20151—
+6K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+6K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+6K141187Impix Alif S/aMedicrea International SA201501
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+6K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142277Juliet POSpineart2014119—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K140280ForticoreNanovis, LLC20149—
+6K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+6K140411Altera SpacerGlobus Medical, Inc.201419122
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K133200Stalif C (R)Centinel Spine, Inc.201410—
+6K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+6K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K140474Juliet OLSpineart2014120—
+6K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K123758Tasmin RSignus Medizintechnik GmbH20141—
+6K133286Midline (TM)Centinel Spine, Inc.2014460—
+6K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+6K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—