SFC VERTEBRAL BODY REPLACEMENT

SFC VERTEBRAL BODY REPLACEMENT is an FDA 510(k)-cleared medical device (K110153) manufactured by Konigsee Implantate 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 October 11, 2011. Regulation: 8.