Product code
QLQ: Manual instruments designed for use with total disc replacement devices
FDA product code · Class II · Orthopedic
Key facts
| Product code | QLQ |
|---|---|
| Device | Manual instruments designed for use with total disc replacement devices |
| Device class | Class II |
| Regulation number | 888.4515 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None 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