MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE

MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE is an FDA 510(k)-cleared medical device (K042606) manufactured by Synthes (Usa). This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 2005. Regulation: 8.