OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM

OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM is an FDA 510(k)-cleared medical device (K991055) 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 26, 1999. Regulation: 8.