PolyLock Small Bone Plating System

PolyLock Small Bone Plating System is an FDA 510(k)-cleared medical device (K192323) manufactured by Fusion Orthopedics, LLC. 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 17, 2019. Regulation: 8.