# QLR: Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

- Device class: 2; regulation: 21 CFR 888.4520; FDA's rule: 510(k) required
- FDA decisions: 1
- 510(k) review time 2021–2025: median 83 days (middle half 83–83)
- 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)
- 2025: 1

## Most-cited predicates
- K253118: Companion Spine DIAM™ Instrumentation (2025), cited by 1

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