# GXO: Strip, Craniosynostosis, Preformed

- Device class: 2; regulation: 21 CFR 882.5900; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1996: 1
- 2004: 1

## Most-cited predicates
- 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 (2004), cited by 2

Source page: https://510kreport.com/product-code/GXO
Data by year (CSV): https://510kreport.com/product-code/GXO.csv