Collagen Dura Regeneration Membrane - Repair

Collagen Dura Regeneration Membrane - Repair is an FDA 510(k)-cleared medical device (K251191) manufactured by Collagen Matrix, 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 November 17, 2025. Regulation: 8.