510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K142277Juliet POSpineart2014119—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K133200Stalif C (R)Centinel Spine, Inc.201410—
+5K140474Juliet OLSpineart2014120—
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133192Mectalif TipeekMedacta International201416—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122047Alamo PAlliance Partners, LLC20120—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K113478Plif CageEisertech, LLC2012269—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+5K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111569Plateau Spacer SystemLife Spine2011181—
+5K110927MectalifMedacta International2011301
+5K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+5K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+5K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+5K082801Phantom Plus Cage SystemUs Spine2008643—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+5K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—