PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING is an FDA 510(k)-cleared medical device (K910755) manufactured by Intermedics Orthopedics. 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 25, 1991. Regulation: 8.