STELKAST ALL POLYETHYLENE ACETABULAR CUP

STELKAST ALL POLYETHYLENE ACETABULAR CUP is an FDA 510(k)-cleared medical device (K953169) 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 August 7, 1995. Regulation: 8.