SIMAL CERVICAL STABILIZATION SYSTEM

SIMAL CERVICAL STABILIZATION SYSTEM is an FDA 510(k)-cleared medical device (K981008) manufactured by Top Surgical Products 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 May 26, 1998. Regulation: 8.