TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) is an FDA 510(k)-cleared medical device (K946348) manufactured by Sofamor Danek USA,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 August 6, 1995. Regulation: 8.