Trigon PEEK HA Wedges

Trigon PEEK HA Wedges is an FDA 510(k)-cleared medical device (K243231) manufactured by Nvision Biomedical Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2024. Regulation: 8.