TRUE/LOK MONOLATERAL/BILATERAL FIXATOR

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR is an FDA 510(k)-cleared medical device (K941048) manufactured by Applied Osteo Systems, 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 October 2, 1994. Regulation: 8.