Trigon™ Ti Stand-Alone Wedge Fixation System

Trigon™ Ti Stand-Alone Wedge Fixation System is an FDA 510(k)-cleared medical device (K192645) 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 22, 2019. Regulation: 8.