510(k) Report

Devices descending from K083475

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K200919Idys ALIF 3DTiClariance20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—