Product code
QPQ: Shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
FDA product code · Class II · Orthopedic
Key facts
| Product code | QPQ |
|---|---|
| Device | Shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed |
| Device class | Class II |
| Regulation number | 888.3630 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 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