StageOne™ Select Hip Cement Spacer Molds

StageOne™ Select Hip Cement Spacer Molds is an FDA 510(k)-cleared medical device (K222760) manufactured by Biomet, 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 December 27, 2022. Regulation: 8.