FDA Product Code GXQ: Dura Substitute
Leading manufacturers include Synthes USA Products, LLC, Helios Biomedical, Inc. and Collagen Matrix, Inc..
FDA 510(k) Cleared Dura Substitute Devices (Product Code GXQ)
About Product Code GXQ - Regulatory Context
510(k) Submission Activity
43 total 510(k) submissions under product code GXQ since 1995, with 43 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for GXQ submissions have been consistent, averaging 153 days recently vs 146 days historically.
GXQ devices are reviewed by the Neurology panel. Browse all Neurology devices →