# PHM: Intervertebral Fusion Device With Bone Graft, Thoracic

- Device class: 2; regulation: 21 CFR 888.3080; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2015: 1
- 2016: 1
- 2018: 1

## Most-cited predicates
- K180480: ATEC Universal Spacer System (2018), cited by 11
- K160958: Battalion Universal Spacer System (2016), cited by 3
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), cited by 2

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