Baby Gorilla/Gorilla Plating System

Baby Gorilla/Gorilla Plating System is an FDA 510(k)-cleared medical device (K221465) manufactured by Paragon 28, 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 June 16, 2022. Regulation: 8.