APEX PS KNEE SYSTEM - PS-C INSERT

APEX PS KNEE SYSTEM - PS-C INSERT is an FDA 510(k)-cleared medical device (K111184) 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 June 21, 2011. Regulation: 8.