Humeral Cup Stability & Humeral Cup 135/145o Stability

Humeral Cup Stability & Humeral Cup 135/145o Stability is an FDA 510(k)-cleared medical device (K193394) manufactured by Fx Shoulder USA, 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 April 28, 2020. Regulation: 8.