510(k) K173458

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System by Orthofix Srl — Product Code HSB

K173458 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System". The FDA issued a decision of Substantially Equivalent on Dec 7, 2017. 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 97 other 510(k) clearances on record.