Medline UNITE® REFLEX® Nitinol Staple System

Medline UNITE® REFLEX® Nitinol Staple System is an FDA 510(k)-cleared medical device (K231885) manufactured by Medline Industries, LP. 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 8, 2023. Regulation: 8.