510(k) Report

Devices descending from K100043

744 later devices reach Coroent XLR Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+1K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+1K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+1K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+1K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+1K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+1K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+1K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+1K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K261408SABER-XA SystemElevation Spine20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+3K250556Porous Biologic ScaffoldVentris Medical20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+3K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+3K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K240442MagnetOs PuttyKuros Biosciences B.V20243—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K240458Synthetic Bone PuttyVentris Medical20242—
+3K240459Cerament Bone Void FillerBonesupport AB20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232347MagnetOs GranulesKuros Biosciences B.V20242—
+3K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+3K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+3K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+3K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232315Catalyst Bone Void FillerOssdsign AB20237—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—