# K033395: Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Feb 25, 2004 after 125 days
- Product code: GXO (Strip, Craniosynostosis, Preformed)
- Device class: 2
- Regulation: 21 CFR 882.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950956 (1995). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 2.
- K991413: Codman Ethisorb Dura Patch, Johnson & Johnson Professionals, Inc. (2000) Summary page 2.
- (no number) Codman Bicol Collagen Sponge: named in the summary without a submission number

## Most influential descendants
- K152481: DURAFORM Dural Graft Implant (2015), 0 descendants of its own
- K041518: Codman Duraform Dural Graft Implant (2004), 0 descendants of its own

## Indications for use
The Codman Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

Source page: https://510kreport.com/device/K033395
Methodology: https://510kreport.com/methodology