510(k) K232169

FITBONE® Transport and Lengthening System by Orthofix Srl — Product Code HSB

K232169 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "FITBONE® Transport and Lengthening System". The FDA issued a decision of Substantially Equivalent on March 22, 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.