TRANSFX EXTERNAL FIXATION SYSTEM

TRANSFX EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K984357) manufactured by Immedica, 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 March 3, 1999. Regulation: 8.