DEPUY AE TK2 HIP SCREW SYSTEM

DEPUY AE TK2 HIP SCREW SYSTEM is an FDA 510(k)-cleared medical device (K972629) manufactured by Depuy, 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 October 8, 1997. Regulation: 8.