510(k) Report

Devices descending from K083475

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K171312FortiCore®Nanovis, LLC20183—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K172065Scarlet AC-TSpineart20172—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+5K263049SABER-C SystemElevation Spine20260—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261049Scala® TLSpineart SA20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—