# OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

- Device class: 2; regulation: 21 CFR 888.3080; FDA's rule: 510(k) required
- FDA decisions: 169
- 510(k) review time 2021–2025: median 92 days (middle half 58–173)
- Recalls: 7 (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: 9
- 2018: 7
- 2019: 7
- 2020: 13
- 2021: 10
- 2022: 10
- 2023: 16
- 2024: 6
- 2025: 10
- 2026: 13

## Most-cited predicates
- K083389: Coalition Spacer (2009), cited by 22
- K102606: Avs Anchor-C Cervical Cage System (2011), cited by 17
- K072981: Synthes Zero-P (2008), cited by 14
- K073285: Peek Prevail Cervical Interbody Device (2008), cited by 14
- K072415: Stalif (TM) C (2008), cited by 13
- K120819: Stalif C (2012), cited by 11
- K151939: COALITION Spacers (2016), cited by 10
- K094042: Peek Prevail Cervical Interbody Device (2010), cited by 9
- K150053: STALIF C; STALIF C-Ti (2015), cited by 9
- K071833: Mosaic Devices (2007), cited by 8

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