StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis is an FDA 510(k)-cleared medical device (K161273) 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 January 24, 2017. Regulation: 8.