# NDF: Plate, Fixation, Bone, Non-Spinal, Metallic

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 3
- 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: 1
- 2002: 1
- 2005: 1

## Most-cited predicates
- K051642: FR.O.H. Calcaneus Repair System (2005), cited by 4
- K010551: Ebi Dynafix VS Osteotomy System (2001), cited by 1

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