AxSOS 3 AF System and AxSOS 3 Ti System

AxSOS 3 AF System and AxSOS 3 Ti System is an FDA 510(k)-cleared medical device (K200398) 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 June 4, 2020. Regulation: 8.