PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP is an FDA 510(k)-cleared medical device (K922733) manufactured by Orthomet, 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 February 8, 1993. Regulation: 8.