# PLR: Spinal Vertebral Body Replacement Device - Cervical

- Device class: 2; regulation: 21 CFR 888.3060; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 231 days (middle half 89–271)
- 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)
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 5
- 2020: 2
- 2022: 2
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System (2015), cited by 9
- K172032: Modulift Vertebral Body Replacement (VBR) System (2017), cited by 6
- K180550: NuVasive Monolith Cervical Corpectomy System (2018), cited by 4
- K152568: C-VBR (2016), cited by 4
- K191778: Omnia Medical VBR (2019), cited by 3
- K180673: Normandy VBR System (2018), cited by 2
- K183071: VLIFT-s Vertebral Body Replacement System (2019), cited by 2
- K191423: Normandy VBR System (2019), cited by 1
- K193412: NEXXT MATRIXX System (2020), cited by 1
- K190426: ALTA Anterior Cervical Corpectomy System (2019), cited by 1

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