EPI-UNION PLATING SYSTEM

EPI-UNION PLATING SYSTEM is an FDA 510(k)-cleared medical device (K974289) manufactured by Howmedica, 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 February 11, 1998. Regulation: 8.