ACROMED CABLE/WIRE PEDICLE SCREW

ACROMED CABLE/WIRE PEDICLE SCREW is an FDA 510(k)-cleared medical device (K964007) manufactured by Acromed 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 December 15, 1996. Regulation: 8.