510(k) K180436

T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System by Stryker Trauma GmbH — Product Code HSB

K180436 is an FDA 510(k) premarket notification submitted by Stryker Trauma GmbH for the device "T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System". The FDA issued a decision of Substantially Equivalent on Jun 6, 2018. 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.