Stryker VariAx 2 MIS Calcaneus

Stryker VariAx 2 MIS Calcaneus is an FDA 510(k)-cleared medical device (K221346) 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 July 7, 2022. Regulation: 8.