ANKLE (FREEMAN-SWANSON)

ANKLE (FREEMAN-SWANSON) is an FDA 510(k)-cleared medical device (K761020) manufactured by Medishield, 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 22, 1976. Regulation: 8.