510(k) Report

Devices descending from K081968

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K200919Idys ALIF 3DTiClariance20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192993Scarlet AL-TSpineart20201—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—