510(k) K253517

Reselute Tibial Nail by Reselute, Inc. — Product Code HSB

K253517 is an FDA 510(k) premarket notification submitted by Reselute, Inc. for the device "Reselute Tibial Nail". The FDA issued a decision of Substantially Equivalent on March 10, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.