IMPLEX RADIAL HEAD REPLACEMENT SYSTEM

IMPLEX RADIAL HEAD REPLACEMENT SYSTEM is an FDA 510(k)-cleared medical device (K984290) manufactured by Implex Corp.. 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 31, 1999. Regulation: 8.