TSRH VARIABLE ANGLE SACRAL SCREW

TSRH VARIABLE ANGLE SACRAL SCREW is an FDA 510(k)-cleared medical device (K904243) manufactured by Danek Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1992. Regulation: 8.