MAGNA-ROM 21 KNEE SYSTEEM

MAGNA-ROM 21 KNEE SYSTEEM is an FDA 510(k)-cleared medical device (K991143) 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 June 10, 1999. Regulation: 8.