# QSR: Sacroiliac Screw Placement Guide

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 1
- 510(k) review time 2021–2025: median 57 days (middle half 57–57)
- 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

## Most-cited predicates
- K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (2022), cited by 1

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