T2 Alpha Tibia Nailing System, IMN Screws System

T2 Alpha Tibia Nailing System, IMN Screws System is an FDA 510(k)-cleared medical device (K193308) manufactured by Stryker Trauma GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2020. Regulation: 8.