Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is an FDA 510(k)-cleared medical device (K253447) manufactured by Orthocon, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2026. Regulation: 8.