510(k) K201147

Elos® Intramedullary Nailing System by Intrauma S.P.A — Product Code HSB

K201147 is an FDA 510(k) premarket notification submitted by Intrauma S.P.A for the device "Elos® Intramedullary Nailing System". The FDA issued a decision of Substantially Equivalent on Jul 19, 2021. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Intrauma S.P.A has at least 2 other 510(k) clearances on record.