# KWQ: Appliance, Fixation, Spinal Intervertebral Body

- Device class: 2; regulation: 21 CFR 888.3060; FDA's rule: 510(k) required
- FDA decisions: 668
- 510(k) review time 2021–2025: median 64 days (middle half 49–110)
- Recalls: 129 (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: 20
- 2018: 22
- 2019: 26
- 2020: 26
- 2021: 17
- 2022: 18
- 2023: 16
- 2024: 17
- 2025: 7
- 2026: 10

## Most-cited predicates
- K030866: Synthes Anterior CSLP System (2003), cited by 42
- K000536: Synthes Anterior CSLP System (2000), cited by 40
- K042025: Modification to CD Horizon Spinal System (2004), cited by 37
- K042544: Uniplate Anterior Cervical Plate System (2004), cited by 26
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System (1995), cited by 24
- K992168: Moss Miami 6.35MM Polyaxial Screw (1999), cited by 22
- K051971: Optima Spinal System (2005), cited by 18
- K994239: Zephir Anterior Cervical Plate System (2000), cited by 16
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (1997), cited by 16
- K000742: Synthes Anterior CSLP System (2000), cited by 16

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