FDA product code NQO: Prosthesis, Spinous Process Spacer/Plate
NQO is the FDA product code for prosthesis, spinous process spacer/plate. It is a Class III device, reviewed by the Orthopedic panel. Devices under NQO reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 6 recalls for NQO devices, 3 initiated in the last five years.
Definition
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Spinous Process Spacer/Plate |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NQO devices
6 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-06-06.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NQO?
NQO is the FDA product code for prosthesis, spinous process spacer/plate. It is a Class III device, reviewed by the Orthopedic panel.
What device class is NQO?
Class III. Typical premarket route: PMA.
Have NQO devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2025-06-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NQO
- Run a recall and safety report across every NQO manufacturer
- Watch product code NQO 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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