510(k) K250112

FitboneTM Trochanteric by Orthofix Srl — Product Code HSB

K250112 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "FitboneTM Trochanteric". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Orthofix Srl has at least 10 other 510(k) clearances on record.