Exactech® Equinoxe® Preserve Stem

Exactech® Equinoxe® Preserve Stem is an FDA 510(k)-cleared medical device (K162726) manufactured by Exactech, 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 31, 2017. Regulation: 8.