# K163456: DuraGen Secure Dural Regeneration Matrix

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Jan 6, 2017 after 28 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950956 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120600: Duragen Secure Dural Regneration Matrix, Integra Life Sciences (2012) Summary page 5.

## Indications for use
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

Source page: https://510kreport.com/device/K163456
Methodology: https://510kreport.com/methodology