ACCOLADE-J HIP STEM SERIES

ACCOLADE-J HIP STEM SERIES is an FDA 510(k)-cleared medical device (K032300) manufactured by Howmedica Osteonics Corp.. 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, 2003. Regulation: 8.