510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+3K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+3K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153621Juliet® TiSpineart2016751
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K140348Interbody CageEisertech, LLC2015235—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K141135Juliet LLSpineart2014146—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K142277Juliet POSpineart2014119—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+3K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+3K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+3K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140474Juliet OLSpineart2014120—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+3K130461Stalif XCentinel Spine, Inc.201313—