# QRR: Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

- Device class: 2; regulation: 21 CFR 888.3046; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 85 days (middle half 85–85)
- 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)
- 2022: 1
- 2024: 1

## Most-cited predicates
- DEN210044: Cerament G (2022), cited by 1

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