Catalyst OrthoScience R1 Reverse Shoulder System

Catalyst OrthoScience R1 Reverse Shoulder System is an FDA 510(k)-cleared medical device (K202611) 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 February 11, 2021. Regulation: 8.