LATITUDE EV™ Total Elbow Arthroplasty

LATITUDE EV™ Total Elbow Arthroplasty is an FDA 510(k)-cleared medical device (K193247) manufactured by Tornier, 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 August 4, 2020. Regulation: 8.