FDA product code NQW: Orthosis, Spine, Plate, Laminoplasty, Metal
NQW is the FDA product code for orthosis, spine, plate, laminoplasty, metal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel. FDA has cleared 30 510(k) submissions under NQW, 5 in the last five years, from 24 different applicants. The average 510(k) review took 98 days (median 88); 142 days on average over the last three years.
Definition
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device class | Class II |
| Regulation | 21 CFR 888.3050 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NQW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 60 |
| 2018 | 2 | 108 |
| 2019 | 2 | 63 |
| 2021 | 1 | 131 |
| 2023 | 2 | 58 |
| 2024 | 2 | 29 |
| 2026 | 1 | 254 |
Compare with all 510(k) review times · Search every NQW clearance
Top NQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Globus Medical, Inc. | 3 | 2017-07-14 |
| Curiteva, Inc. | 2 | 2024-10-28 |
| Vy Spine, LLC | 2 | 2024-10-16 |
| Life Spine, Inc. | 2 | 2019-09-20 |
| Seaspine, Inc. | 2 | 2015-03-23 |
19 more applicants have NQW clearances. See the full list in Caduvo.
Most recent NQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252930 | ZheJiang Decans Medical Devices Co., Ltd. | AQUA Laminoplasty Systems | 2026-05-27 | 254 |
| K243137 | Curiteva, Inc. | Curiteva Porous PEEK Laminoplasty System | 2024-10-28 | 28 |
| K242784 | Vy Spine, LLC | Vy Spine VyLam Laminoplasty System | 2024-10-16 | 30 |
| K232471 | Vy Spine, LLC | Vy Spine VyLam Laminoplasty System | 2023-10-10 | 55 |
| K231232 | Curiteva, Inc. | Curiteva Laminoplasty System | 2023-06-28 | 61 |
Recalls for NQW devices
openFDA lists no recalls for product code NQW.
Frequently asked questions
What is FDA product code NQW?
NQW is the FDA product code for orthosis, spine, plate, laminoplasty, metal. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel.
What device class is NQW?
Class II, regulation 21 CFR 888.3050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQW?
Across 30 cleared submissions the average was 98 days from receipt to decision (median 88).
Which companies have the most NQW clearances?
Globus Medical, Inc. (3); Curiteva, Inc. (2); Vy Spine, LLC (2); Life Spine, Inc. (2); Seaspine, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NQW
- Run a recall and safety report across every NQW manufacturer
- Watch product code NQW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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