RESTORATION ACETABULAR WEDGE AUGMENTS

RESTORATION ACETABULAR WEDGE AUGMENTS is an FDA 510(k)-cleared medical device (K102019) manufactured by Howmedica Osteonics. 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 2, 2011. Regulation: 8.