510(k) K191617

Syntec Tibial Nail System by Syntec Scientific Corporation — Product Code HSB

K191617 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corporation for the device "Syntec Tibial Nail System". The FDA issued a decision of Substantially Equivalent on September 3, 2019. 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.