# OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

- Device class: 2; regulation: 21 CFR 888.3080; FDA's rule: 510(k) required
- FDA decisions: 205
- 510(k) review time 2021–2025: median 108 days (middle half 76–149)
- Recalls: 9 (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: 12
- 2018: 14
- 2019: 12
- 2020: 14
- 2021: 7
- 2022: 14
- 2023: 12
- 2024: 12
- 2025: 10
- 2026: 8

## Most-cited predicates
- K073109: Stalif TT Intervertebral Body Fusion System (2008), cited by 32
- K072253: Synfix-LR Spacer (2007), cited by 28
- K123045: Brigade Standalone System (2013), cited by 17
- K103382: Intercontinental Plate-Spacer (2011), cited by 13
- K082252: Independence Spacer (2008), cited by 13
- K161379: ELSA Spacers (2016), cited by 13
- K100516: Anyplus Peek Cages (2010), cited by 12
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), cited by 12
- K101310: VU Apod Intervertebral Body Fusion Device (2010), cited by 11
- K100043: Coroent XLR Standalone System (2010), cited by 11

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