VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System is an FDA 510(k)-cleared medical device (K212581) 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 January 18, 2022. Regulation: 8.