IMPLEX SCREW AND WASHER SYSTEM

IMPLEX SCREW AND WASHER SYSTEM is an FDA 510(k)-cleared medical device (K982751) 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 January 31, 1999. Regulation: 8.