MODIFIED PROFILE HIP PMMA CEMENT SPACER

MODIFIED PROFILE HIP PMMA CEMENT SPACER is an FDA 510(k)-cleared medical device (K871510) manufactured by Depuy, 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 May 26, 1987. Regulation: 8.