Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is an FDA 510(k)-cleared medical device (K213328) manufactured by Stryker 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 10, 2022. Regulation: 8.