510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—