NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW

NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW is an FDA 510(k)-cleared medical device (K931651) manufactured by Intermedics Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 1994. Regulation: 8.