Trigon HA Stand-Alone Wedge Fixation System

Trigon HA Stand-Alone Wedge Fixation System is an FDA 510(k)-cleared medical device (K203445) manufactured by Nvision Biomedical Technologies, 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 December 20, 2020. Regulation: 8.