K-CAP-E, STERILE

K-CAP-E, STERILE is an FDA 510(k)-cleared medical device (K914812) manufactured by Westcon 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 January 8, 1992. Regulation: 8.