Product code
QHP: Vertebral body tethering system
FDA product code · Not Classified · Orthopedic
Key facts
| Product code | QHP |
|---|---|
| Device | Vertebral body tethering system |
| Device class | Not Classified |
| Review panel | Orthopedic |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 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