MODIFICATION TO SYNTHES (USA) POLYPIN

MODIFICATION TO SYNTHES (USA) POLYPIN is an FDA 510(k)-cleared medical device (K003527) 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 8, 2001. Regulation: 8.