TIMX LOW BACK SYSTEM

TIMX LOW BACK SYSTEM is an FDA 510(k)-cleared medical device (K984348) manufactured by Depuy Motech Acromed. 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, 1999. Regulation: 8.