Baby Gorilla®/Gorilla® Plating System

Baby Gorilla®/Gorilla® Plating System is an FDA 510(k)-cleared medical device (K250952) 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 July 17, 2025. Regulation: 8.