# K061208: Lifecell Dural Substitute Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Jan 3, 2007 after 247 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). 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)
- K043427: Duragen II Dural Regeneration Matrix, Integra Lifesciences Corp. (2005) Summary page 2.
- K982282: Dura-Guard - Dural Repair Patch, Bio-Vascular, Inc. (1998) Summary page 2.

## Indications for use
LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

Source page: https://510kreport.com/device/K061208
Methodology: https://510kreport.com/methodology