Catalyst CSR Press-Fit Humeral Components

Catalyst CSR Press-Fit Humeral Components is an FDA 510(k)-cleared medical device (K182500) manufactured by Catalyst Orthoscience, 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 10, 2019. Regulation: 8.