MODIFICATION OF TSRH SPINAL SYSTEM

MODIFICATION OF TSRH SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K984522) 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 5, 1999. Regulation: 8.