StageOne™ Shoulder Cement Spacer Molds

StageOne™ Shoulder Cement Spacer Molds is an FDA 510(k)-cleared medical device (K221968) 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 September 14, 2022. Regulation: 8.