510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+2K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153621Juliet® TiSpineart2016751
+2K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+2K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K140348Interbody CageEisertech, LLC2015235—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K141135Juliet LLSpineart2014146—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K142277Juliet POSpineart2014119—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+2K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K140474Juliet OLSpineart2014120—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130461Stalif XCentinel Spine, Inc.201313—
+2K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K130630Plateau Spacer System TitaniumLife Spine, Inc.201317—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+2K123913Latis SpacerGlobus Medical, Inc.201388—
+2K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+2K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+2K122097Patriot SpacersGlobus Medical, Inc.2012261—
+2K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+2K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+2K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+2K120101Independence SpacerGlobus Medical, Inc.2012224—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc.201114—
+2K102293Caliber SpacerGlobus Medical, Inc.2011869—
+2K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+2K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+2K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—