SYNTHES 6.5MM MIDFOOT FUSION BOLT

SYNTHES 6.5MM MIDFOOT FUSION BOLT is an FDA 510(k)-cleared medical device (K081071) 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 April 30, 2008. Regulation: 8.