FDA Product Code GXQ: Dura Substitute
Leading manufacturers include Synthes USA Products, LLC and Collagen Matrix, Inc..
2
Total
2
Cleared
175d
Avg days
2022
Since
List of Dura Substitute devices cleared through 510(k)
2 devices
Cleared
Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
Collagen Matrix, Inc.
Neurology
215d
Cleared
Jan 28, 2022
SyntheCel Dura Repair
Synthes USA Products, LLC
Neurology
135d
How to use this database
This page lists all FDA 510(k) submissions for Dura Substitute devices (product code GXQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →