# MQZ: Prosthesis, Nail

- Device class: U; regulation: 21 CFR —
- FDA decisions: 4
- 510(k) review time 2021–2025: median 300 days (middle half 300–300)
- 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)
- 1985: 1
- 1996: 1
- 2018: 1
- 2024: 1

## Most-cited predicates
- K960843: Stop-N-Grow (1996), cited by 1
- K162525: Oniko nail brace (2018), cited by 1

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