# OQB: Intervertebral Body Graft Containment Device

- Device class: 2; regulation: 21 CFR 888.3085; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 212 days (middle half 168–222)
- 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
- 2023: 2
- 2025: 1

## Most-cited predicates
- DEN200010: Spineology Interbody Fusion System (2020), cited by 1
- K230927: OptiMesh Multiplanar Expandable Interbody Fusion System (2023), cited by 1

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