# QAC: Screw Sleeve Bone Fixation Device

- Device class: 2; regulation: 21 CFR 888.3043; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 2020: 1

## Most-cited predicates
- DEN180065: OGmend Implant System (2020), cited by 1

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