TSRH OPEN HEAD BONE SCREW

TSRH OPEN HEAD BONE SCREW is an FDA 510(k)-cleared medical device (K911319) 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 September 5, 1991. Regulation: 8.