SYNTHES (U.S.A.) POLYPIN

SYNTHES (U.S.A.) POLYPIN is an FDA 510(k)-cleared medical device (K961608) 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 May 8, 1997. Regulation: 8.