510(k) Report

Devices descending from K071795

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171151ACRON™ TLIF SystemSpinemed Ges.M.B.H20180—
+1K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+1K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+1K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+1K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K141896Coroent SystemNu Vasive, Incorporated2014480—
+1K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+1K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+1K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+1K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+1K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+1K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+1K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+1K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+1K123758Tasmin RSignus Medizintechnik GmbH20141—
+1K132601Coroent Sterile Implants SystemNu Vasive, Incorporated2013596—
+1K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+1K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+1K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K120918Nuvasive Coroent Titanium SystemNuvasive, Inc.2012642—
+1K121116Plateau Spacer SystemLife Spine201213—
+1K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+1K113138Aleutian SystemK2m, Inc.2012549—
+1K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+1K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+1K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+1K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+1K103666Lanx LateralLanx, Inc.2011238—
+1K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+1K092815S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc.2010156
+1K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+1K090425Guided Lateral Interbody Fusion (Glif) SystemAlphatec Spine, Inc.2009319—
+1K081673Dyn-Alif Anterolateral Intervertebral Body Fusion DeviceIonics Medical Corp.20080—
+1K082128Depuy Spine Lateral Cage SystemDepuy Spine2008933—
+1K082235Blackstone Pillar XL Peek SpacersBlackstone Medical, Inc.2008693—
+2K261049Scala® TLSpineart SA20260—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+2K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K170235Lucent®Spinal Elements, Inc.2017107—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—