DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)

DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) is an FDA 510(k)-cleared medical device (K990849) 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 December 19, 1999. Regulation: 8.