Kyphon HV-R Bone Cement

Kyphon HV-R Bone Cement is an FDA 510(k)-cleared medical device (K160983) 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 August 23, 2016. Regulation: 8.