# MRI: Orthosis, Truncal/Orthosis, Limb

- Device class: 1; regulation: 21 CFR 890.3490; FDA's rule: 510(k) exempt
- 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
- 1997: 1

## Most-cited predicates
- K973031: Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste (1997), cited by 1

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