# NQW: Orthosis, Spine, Plate, Laminoplasty, Metal

- Device class: 2; regulation: 21 CFR 888.3050; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 55 days (middle half 30–61)
- 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)
- 2013: 3
- 2015: 1
- 2016: 2
- 2017: 1
- 2018: 2
- 2019: 2
- 2021: 1
- 2023: 2
- 2024: 2
- 2026: 1

## Most-cited predicates
- K032534: Synthes Afs (2004), cited by 18
- K050082: Centerpiece Plate Fixation System (2005), cited by 12
- K091994: Mountaineer Laminoplasty System (2010), cited by 7
- K080664: Relieve Laminoplasty Fixation System (2008), cited by 4
- K043338: Blakstone Laminoplasty Fixation System (2005), cited by 3
- K091623: Laminoplasty Fixation System (2009), cited by 3
- K100805: Gallery Laminoplasty Fixation System (2010), cited by 2
- K121732: Canopy Laminoplasty Fixation System (2012), cited by 2
- K173215: Choice Spine Laminoplasty™ Fixation System (2018), cited by 2
- K113802: Escalate Laminoplasty System (2012), cited by 2

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