SEMIAL SPINAL IMPLANT

SEMIAL SPINAL IMPLANT is an FDA 510(k)-cleared medical device (K051659) 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 July 12, 2005. Regulation: 8.