510(k) Report

Devices descending from K083475

834 later devices reach Lucent Magnum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+1K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+1K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+1K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+1K201671A-Link ZAcuity Surgical Devices, LLC202125—
+1K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+1K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+1K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+1K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+1K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+2K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K222561AlignAcuity Surgical Devices, LLC202214—
+2K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+2K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+2K220610SOLO-LAurora Spine, Inc.20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+2K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K181818Scarlet AL-TSpineart201864—
+2K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+2K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K124034Mectalif AnteriorMedacta International201311—
+2K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+2K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—