NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM

NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM is an FDA 510(k)-cleared medical device (K022323) manufactured by Osteomedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2002. Regulation: 8.