BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT is an FDA 510(k)-cleared medical device (K991398) manufactured by Stryker Leibinger. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 1999. Regulation: 8.