510(k) K233867

Fitbone Trochanteric by Orthofix Srl — Product Code HSB

K233867 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "Fitbone Trochanteric". The FDA issued a decision of Substantially Equivalent on June 18, 2024. 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.