Medline UNITE REFLEX Nitinol Staple System

Medline UNITE REFLEX Nitinol Staple System is an FDA 510(k)-cleared medical device (K210482) manufactured by Medline Industries, 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 21, 2021. Regulation: 8.