KYPHON HV-R Bone Cement

KYPHON HV-R Bone Cement is an FDA 510(k)-cleared medical device (K180700) manufactured by Medtronic Sofamor Danek 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 May 17, 2018. Regulation: 8.