PROTRACT PRESS FIT HIP STEM-HA COATED

PROTRACT PRESS FIT HIP STEM-HA COATED is an FDA 510(k)-cleared medical device (K010241) manufactured by Stelkast Company. 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 7, 2001. Regulation: 8.