510(k) K131005

EBA2 FEMORAL NAILING SYSTEM by Citieffe S.R.L. — Product Code HSB

K131005 is an FDA 510(k) premarket notification submitted by Citieffe S.R.L. for the device "EBA2 FEMORAL NAILING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2013. 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.