# DZK: Wire, Fixation, Intraosseous

- Device class: 2; regulation: 21 CFR 872.4880; 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)
- 2002: 1
- 2010: 1

## Most-cited predicates
- K022821: Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E (2002), cited by 2
- K092530: Sprytie, Models ST001, ST002 and ST003 (2010), cited by 1

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