KYPHON (R) HV-R(R) Bone Cement

KYPHON (R) HV-R(R) Bone Cement is an FDA 510(k)-cleared medical device (K150460) manufactured by Medtronic Sofamor Danck USA, 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 April 27, 2015. Regulation: 8.