Product code
NXM: Prosthesis, eyelid spacer/graft, biologic
FDA product code · Class II · Ophthalmic
Key facts
| Product code | NXM |
|---|---|
| Device | Prosthesis, eyelid spacer/graft, biologic |
| Device class | Class II |
| Regulation number | 886.3130 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 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