MEDINAUT KYPHOPLASTY SYSTEM

MEDINAUT KYPHOPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K133669) manufactured by Imedicom. 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 3, 2014. Regulation: 8.