510(k) Report

Devices descending from K123045

696 later devices reach Brigade Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+1K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+1K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+1K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+1K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+1K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+1K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+1K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+1K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+1K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+1K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+1K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+1K142487Chesapeake Stabilization SystemK2m, Inc.201571
+1K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+1K141942Midline II TICentinel Spine, Inc.2014459—
+1K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K261408SABER-XA SystemElevation Spine20260—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+2K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+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—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+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—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+2K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+2K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+2K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+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—
+2K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+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
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+2K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+2K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+2K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+3K261049Scala® TLSpineart SA20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—