ICONACY(TM) I-Hip (TM)

ICONACY(TM) I-Hip (TM) is an FDA 510(k)-cleared medical device (K151307) manufactured by Iconacy Orthopedic Implants, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2016. Regulation: 8.