TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM

TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM is an FDA 510(k)-cleared medical device (K981714) manufactured by Acromed Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 1998. Regulation: 8.