Stratum® Ankle Fusion Plating System

Stratum® Ankle Fusion Plating System is an FDA 510(k)-cleared medical device (K212640) manufactured by Nextremity Solutions, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2021. Regulation: 8.