SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE

SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE is an FDA 510(k)-cleared medical device (K915818) 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 January 16, 1992. Regulation: 8.