APR ACETABULAR INSERTS IOI BIPOLAR

APR ACETABULAR INSERTS IOI BIPOLAR is an FDA 510(k)-cleared medical device (K935585) 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 December 12, 1995. Regulation: 8.