510(k) K252961

Fusion FibFix Nail by Fusion Orthopedics USA, LLC — Product Code HSB

K252961 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics USA, LLC for the device "Fusion FibFix Nail". The FDA issued a decision of Substantially Equivalent on March 18, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.