PROTEK LOW PROFILE ACETABULAR CUP

PROTEK LOW PROFILE ACETABULAR CUP is an FDA 510(k)-cleared medical device (K960025) 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 June 6, 1996. Regulation: 8.