# K092388: Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, MO

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jan 21, 2010 after 169 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: 4 generations back to K950956 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032693: Duragen Plus Dural Graft Matrix, Integra Lifesciences Corp. (2003) Summary page 1.

## Indications for use
DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix is indicated as a dura substitute for the repair of dura mater. Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater

Source page: https://510kreport.com/device/K092388
Methodology: https://510kreport.com/methodology