510(k) Report

Devices descending from K071724

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K230026SqualeImplanet, S.A.20230—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K181014Tritanium PL CageStryker Spine2018137—
+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—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K171425Concorde LiftMedos International SARL201782
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—