MOBIS SPINAL IMPLANT

MOBIS SPINAL IMPLANT is an FDA 510(k)-cleared medical device (K061082) 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 December 17, 2006. Regulation: 8.