510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—