# OJB: Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

- Device class: 2; regulation: 21 CFR 888.3060; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2005: 1
- 2008: 1
- 2015: 1

## Most-cited predicates
- K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System (2005), cited by 1
- K071810: Inion Spinal Graft Containment System (2008), cited by 1

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