TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)

TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) is an FDA 510(k)-cleared medical device (K901005) 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 December 9, 1990. Regulation: 8.