SWANSON TITANIUM GREAT TOE IMPLANT

SWANSON TITANIUM GREAT TOE IMPLANT is an FDA 510(k)-cleared medical device (K864492) manufactured by Dow Corning Wright. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1987. Regulation: 8.