MONOBLOCK PRESS-FIT HIP STEM

MONOBLOCK PRESS-FIT HIP STEM is an FDA 510(k)-cleared medical device (K060072) manufactured by Omni Life Science, 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 August 23, 2006. Regulation: 8.