PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT

PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT is an FDA 510(k)-cleared medical device (K893762) manufactured by Orthomet, 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 14, 1989. Regulation: 8.