510(k) Report

Devices descending from K110632

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+1K182584Lucent® XPSpinal Elements, Inc.20183—
+1K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+1K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+1K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+1K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+1K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+1K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+1K132596Proposed OptimusCustom Spine, Inc.201451
+1K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+1K122967LucentSpinal Elements, Inc.2013615—
+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—
+2K234150Lucent® XPSpinal Elements20240—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+2K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+2K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+2K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K193541NuVasive Cohere Thoracolumbar Interbody 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—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183259Idys™ TLIF TiVacClariance, Sas20191—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+2K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K170235Lucent®Spinal Elements, Inc.2017107—
+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—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+2K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+2K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K160291Optimus ALIF SystemAmendia, Inc.20160—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+2K133967Interbody Cage SystemAurora Spine2014227—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+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—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+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—