510(k) Report

Devices descending from K122967

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+1K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+1K170235Lucent®Spinal Elements, Inc.2017107—
+1K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+1K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+1K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+1K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+1K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+1K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+2K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K183259Idys™ TLIF TiVacClariance, Sas20191—
+2K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+2K182584Lucent® XPSpinal Elements, Inc.20183—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+3K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K234150Lucent® XPSpinal Elements20240—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—