# K120600: Duragen Secure Dural Regneration Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Integra Life Sciences
- Decided: Jun 15, 2012 after 108 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: 5 generations back to K950956 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072207: Duragen XS Dural Regeneration Matrix, Integra Lifesciences Corp. (2007) Summary page 1.

## Most influential descendants
- K163456: DuraGen Secure Dural Regeneration Matrix (2017), 0 descendants of its own

## 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/K120600
Methodology: https://510kreport.com/methodology