SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE

SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE is an FDA 510(k)-cleared medical device (K905451) 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 4, 1991. Regulation: 8.