FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM

FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM is an FDA 510(k)-cleared medical device (K992287) manufactured by Howmedica Osteonics 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 November 15, 1999. Regulation: 8.