510(k) K193308

T2 Alpha Tibia Nailing System, IMN Screws System by Stryker Trauma GmbH — Product Code HSB

K193308 is an FDA 510(k) premarket notification submitted by Stryker Trauma GmbH for the device "T2 Alpha Tibia Nailing System, IMN Screws System". The FDA issued a decision of Substantially Equivalent on Feb 23, 2020. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Stryker Trauma GmbH has 31 other 510(k) clearances on record.