# OAR: Injector, Vertebroplasty (Does Not Contain Cement)

- Device class: 1; regulation: 21 CFR 888.4200; FDA's rule: 510(k) exempt
- FDA decisions: 1
- Recalls: 3 (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

## Most-cited predicates
- K051820: Parallax Ezflow Cement Delivery System (2005), cited by 1

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