NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT

NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT is an FDA 510(k)-cleared medical device (K912663) 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 September 15, 1991. Regulation: 8.