Kyocera Bipolar Hip System

Kyocera Bipolar Hip System is an FDA 510(k)-cleared medical device (K200709) manufactured by Kyocera Medical Technologies, 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 April 16, 2020. Regulation: 8.