PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING

PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING is an FDA 510(k)-cleared medical device (K992025) 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 August 12, 1999. Regulation: 8.