TRIGEN Low Profile Bone Screws

TRIGEN Low Profile Bone Screws is an FDA 510(k)-cleared medical device (K161264) manufactured by Smith & Nephew, 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 November 22, 2016. Regulation: 8.