DUREPAIR DURA REGENERATION MATRIX

DUREPAIR DURA REGENERATION MATRIX is an FDA 510(k)-cleared medical device (K041000) manufactured by Medtronic Neurosurgery. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2004. Regulation: 8.