HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM

HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM is an FDA 510(k)-cleared medical device (K930836) 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 January 17, 1995. Regulation: 8.