SYNTHS ONE-THIRD TUBULAR DCL PLATE

SYNTHS ONE-THIRD TUBULAR DCL PLATE is an FDA 510(k)-cleared medical device (K011335) manufactured by Synthes (Usa). 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 26, 2001. Regulation: 8.