Product code
PJY: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
FDA product code · Class III · Orthopedic
Key facts
| Product code | PJY |
|---|---|
| Device | Osseoanchored prostheses for the rehabilitation of transfemoral amputees |
| Device class | Class III |
| Review panel | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 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