APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) is an FDA 510(k)-cleared medical device (K954800) 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 April 24, 1996. Regulation: 8.