510(k) K181540

Estremo Citieffe Nailing System by Citieffe S.R.L. — Product Code HSB

K181540 is an FDA 510(k) premarket notification submitted by Citieffe S.R.L. for the device "Estremo Citieffe Nailing System". The FDA issued a decision of Substantially Equivalent on January 16, 2019. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Citieffe S.R.L. has at least 10 other 510(k) clearances on record.