Product code
PIX: Elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis
FDA product code · Not Classified · Orthopedic
Key facts
| Product code | PIX |
|---|---|
| Device | Elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis |
| Device class | Not Classified |
| Review panel | Orthopedic |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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