TriMed Nitinol Staple System

TriMed Nitinol Staple System is an FDA 510(k)-cleared medical device (K190166) manufactured by TriMed, 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 June 30, 2019. Regulation: 8.