510(k) Report

Devices descending from K073348

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K152622Alta ACDF SystemBiomet Spine20160—
+8K263049SABER-C SystemElevation Spine20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—