NQW
- Product code
- NQW
- Device name
- Orthosis, Spine, Plate, Laminoplasty, Metal
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3050
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 30
FDA classification definition
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252930 | 2026-05-27 | ZheJiang Decans Medical Devices Co., L | AQUA Laminoplasty Systems | |
| K243137 | 2024-10-28 | Curiteva, Inc. | Curiteva Porous PEEK Laminoplasty System | |
| K242784 | 2024-10-16 | Vy Spine, LLC | Vy Spine VyLam Laminoplasty System | |
| K232471 | 2023-10-10 | Vy Spine, LLC | Vy Spine VyLam Laminoplasty System |
Official FDA classification page: NQW
Classification and pathway per current FDA publications. Data from openFDA (CC0).