EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM

EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K140547) manufactured by Excera 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 21, 2015. Regulation: 8.