OSTEONICS HA-COATED DEVICES

OSTEONICS HA-COATED DEVICES is an FDA 510(k)-cleared medical device (K980070) 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 July 22, 1999. Regulation: 8.