SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM

SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K994128) manufactured by Howmedica Osteonics 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 March 5, 2000. Regulation: 8.