510(k) Report

Devices descending from K071724

1,174 later devices reach Lucent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162262Tritanium® PL CageStryker2016132—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160955Tritanium® PL CageStryker2016178—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—