APOLLO REVISION/CONSTRAINED KNEE SYSTEM

APOLLO REVISION/CONSTRAINED KNEE SYSTEM is an FDA 510(k)-cleared medical device (K972501) manufactured by Sulzer Orthopedics, 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 30, 1997. Regulation: 8.