# NVR: Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 6
- Recalls: 17 (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)
- 2005: 1
- 2007: 3
- 2008: 2

## Most-cited predicates
- K051320: Satellite Spinal System (2005), cited by 4
- K060415: Modification to: Satellite Spinal System (2007), cited by 2
- K062992: Spinal Spheres (2007), cited by 1

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