OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS is an FDA 510(k)-cleared medical device (K983152) 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 September 24, 1998. Regulation: 8.