StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is an FDA 510(k)-cleared medical device (K160071) 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 June 15, 2016. Regulation: 8.