STABLELOC II EXTERNAL FIXATOR

STABLELOC II EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K965029) manufactured by Acu Med, 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 February 18, 1997. Regulation: 8.