Medline UNITE® REFLEX® Nitinol Staple Kit

Medline UNITE® REFLEX® Nitinol Staple Kit is an FDA 510(k)-cleared medical device (K232905) 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 October 18, 2023. Regulation: 8.