OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM

OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM is an FDA 510(k)-cleared medical device (K921480) 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 June 25, 1992. Regulation: 8.