510(k) K203811

GPC Intraheal Intramedullary Nailing System by Gpc Medical Limited — Product Code HSB

K203811 is an FDA 510(k) premarket notification submitted by Gpc Medical Limited for the device "GPC Intraheal Intramedullary Nailing System". The FDA issued a decision of Substantially Equivalent on Feb 10, 2022. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Gpc Medical Limited has 3 other 510(k) clearances on record.