TOSCA II ANTERIOR CERVICAL PLATE SYSTEM

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM is an FDA 510(k)-cleared medical device (K080815) manufactured by Signus Medizintechnik GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2008. Regulation: 8.