510(k) Report

Devices descending from K073348

1,021 later devices reach Lucent Magnum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+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—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—