PARALOCK PLATING SYSTEM / TUFFNEK SCREW

PARALOCK PLATING SYSTEM / TUFFNEK SCREW is an FDA 510(k)-cleared medical device (K140397) manufactured by Paragon 28. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2014. Regulation: 8.