510(k) K202935

Syntec Femoral Nail Extended System by Syntec Scientific Corporation — Product Code HSB

K202935 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corporation for the device "Syntec Femoral Nail Extended System". The FDA issued a decision of Substantially Equivalent on October 28, 2020. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Syntec Scientific Corporation has at least 5 other 510(k) clearances on record.