CODMAN SOF'WIRE (TM) KIT

CODMAN SOF'WIRE (TM) KIT is an FDA 510(k)-cleared medical device (K915581) manufactured by Codman & Shurtleff, 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 15, 1992. Regulation: 8.