510(k) K253291

Excelsior System by Blue Ocean Global — Product Code KTT

K253291 is an FDA 510(k) premarket notification submitted by Blue Ocean Global for the device "Excelsior System". The FDA issued a decision of Substantially Equivalent on January 20, 2026. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030.