SYSTEM TEN MODEL 100 SURGICAL SYSTEM

SYSTEM TEN MODEL 100 SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K900003) manufactured by Advanced Osseous Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 1990. Regulation: 8.