ICONACY I-HIP SYSTEM

ICONACY I-HIP SYSTEM is an FDA 510(k)-cleared medical device (K131279) 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 August 8, 2013. Regulation: 8.