TSRH SPINAL SCREWS

TSRH SPINAL SCREWS is an FDA 510(k)-cleared medical device (K932029) manufactured by Sofamor Danek Mfg., 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 19, 1995. Regulation: 8.