OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS

OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS is an FDA 510(k)-cleared medical device (K990059) 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 January 27, 1999. Regulation: 8.