510(k) Report

Devices descending from K081968

716 later devices reach Modification to Lucent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+1K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+1K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+1K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+1K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+1K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K123100Intess Lumbar CageKalitec Direct, LLC20135—
+1K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+2K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+2K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153621Juliet® TiSpineart2016751
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+4K261049Scala® TLSpineart SA20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—