510(k) Report

Devices descending from K110632

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+4K192993Scarlet AL-TSpineart20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181397DualXInnovasive, Inc.201815—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+4K143479Bluefin Interbody SystemTides Medical20152—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—