OSTEONICS(R) 6011 HIP STEM SERIES

OSTEONICS(R) 6011 HIP STEM SERIES is an FDA 510(k)-cleared medical device (K905158) manufactured by 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 January 3, 1991. Regulation: 8.