TriMed Humeral Supracondylar Fixation System

TriMed Humeral Supracondylar Fixation System is an FDA 510(k)-cleared medical device (K151735) 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 January 28, 2016. Regulation: 8.