Kyphon Xpede Bone Cement

Kyphon Xpede Bone Cement is an FDA 510(k)-cleared medical device (K163032) manufactured by Medtronic, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2017. Regulation: 8.