# ODP: Intervertebral Fusion Device With Bone Graft, Cervical

- Device class: 2; regulation: 21 CFR 888.3080; FDA's rule: 510(k) required
- FDA decisions: 354
- 510(k) review time 2021–2025: median 116 days (middle half 64–241)
- Recalls: 6 (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)
- 2017: 33
- 2018: 25
- 2019: 22
- 2020: 14
- 2021: 18
- 2022: 12
- 2023: 34
- 2024: 10
- 2025: 11
- 2026: 19

## Most-cited predicates
- K091088: LDR Spine Cervical Interbody Fusion System (2009), cited by 51
- K073351: Crystal (2008), cited by 27
- K160125: Cascadia Interbody System (2016), cited by 21
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants (2011), cited by 21
- K081611: Nuvasive Coroent System (2008), cited by 18
- K081730: Novel Cervical Spinal Spacer System (2008), cited by 16
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty (2022), cited by 14
- K171140: Matrixx System (2017), cited by 14
- K163491: NuVasive CoRoent Small Interbody System (2017), cited by 13
- K082801: Phantom Plus Cage System (2008), cited by 13

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