# LOE: Stimulator, Invasive Bone Growth

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 4
- 2014: 2
- 2015: 4
- 2016: 4
- 2017: 4
- 2018: 16
- 2019: 4
- 2021: 2
- 2022: 4
- 2024: 1

## Most-cited predicates

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