SMARTSCREW MODEL 222006...227510

SMARTSCREW MODEL 222006...227510 is an FDA 510(k)-cleared medical device (K003077) manufactured by Bionx Implants, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 25, 2001. Regulation: 8.