510(k) K251400

T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System by Stryker GmbH — Product Code HSB

K251400 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System". The FDA issued a decision of Substantially Equivalent on August 20, 2025. 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 at least 10 other 510(k) clearances on record.