HI-NEK TOTAL HIP

HI-NEK TOTAL HIP is an FDA 510(k)-cleared medical device (K873632) manufactured by Orthopedic Systems, 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 December 6, 1987. Regulation: 8.