Product code
NQO: Prosthesis, spinous process spacer/plate
FDA product code · Class III · Orthopedic
Key facts
| Product code | NQO |
|---|---|
| Device | Prosthesis, spinous process spacer/plate |
| Device class | Class III |
| Review panel | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database