I-HIP TOTAL HIP SYSTEM

I-HIP TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K132572) 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 March 27, 2014. Regulation: 8.