EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)

EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) is an FDA 510(k)-cleared medical device (K852397) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 1985. Regulation: 8.