KMC KYPHOPLASTY SYSTEM

KMC KYPHOPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K113742) manufactured by Shanghai Kinetic Medical Co., 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 September 16, 2012. Regulation: 8.