510(k) K203819

T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System by Stryker GmbH — Product Code HSB

K203819 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System". The FDA issued a decision of Substantially Equivalent on Feb 26, 2021. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Stryker GmbH has 270 other 510(k) clearances on record.