510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K160291Optimus ALIF SystemAmendia, Inc.20160—
+6K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K142744Mecta-C TiPEEKMedacta International201512—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K142277Juliet POSpineart2014119—
+6K141791Biomet Fusion SystemBiomet Spine2014128—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K133200Stalif C (R)Centinel Spine, Inc.201410—
+6K140474Juliet OLSpineart2014120—
+6K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K133192Mectalif TipeekMedacta International201416—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+6K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+6K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+6K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+6K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+6K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K131547Lanx Fusion SystemLanx, Inc.20131631
+6K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+6K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+6K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+6K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+6K122047Alamo PAlliance Partners, LLC20120—
+6K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+6K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+6K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+6K113478Plif CageEisertech, LLC2012269—
+6K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+6K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+6K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+6K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+6K111569Plateau Spacer SystemLife Spine2011181—
+6K110927MectalifMedacta International2011301
+6K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+6K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+6K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+6K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+6K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+6K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+6K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+6K082801Phantom Plus Cage SystemUs Spine2008643—
+6K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+6K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+6K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—