510(k) K253640

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System by Stryker GmbH — Product Code HSB

K253640 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System". The FDA issued a decision of Substantially Equivalent on February 3, 2026. 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.