# NDL: Pin, Fixation, Smooth, Metallic

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (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)
- 2001: 2

## Most-cited predicates
- K010545: TBW (2001), cited by 4

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