510(k) Report

Devices descending from K013382

1,110 later devices reach Modification to: Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K140348Interbody CageEisertech, LLC2015235—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140411Altera SpacerGlobus Medical, Inc.201419122
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+4K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+4K130445Vault Alif SystemSpinal USA20139—
+4K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+4K123231Caliber SpacersGlobus Medical, Inc.2013657—
+4K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+4K121581Box Peek VBR System,Innovasis, Inc.20121—
+4K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—