ROPER-TUKE ELBOW

ROPER-TUKE ELBOW is an FDA 510(k)-cleared medical device (K873660) manufactured by Orthopedic Systems, 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 January 5, 1988. Regulation: 8.