HOWMEDICA(R) HNR SYSTEM

HOWMEDICA(R) HNR SYSTEM is an FDA 510(k)-cleared medical device (K922503) manufactured by Howmedica Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 1992. Regulation: 8.