| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3026616094 | 3026616094 | NEURAMEDICA INC. | 1 | N | 2026-01-01 | 1515 7th St STE A Oregon City OR US 97045 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860007130403 | DuraFuse Dural Clip - NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument. | 503-914-0723 | rachel@NeuraMedica.com |
| 00860007130410 | DuraFuse Dural Clip Applier - The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. | 503-914-0723 | rachel@NeuraMedica.com |
| 00860007130427 | DuraFuse Dural Clip Instrument Tray - The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. | 503-914-0723 | rachel@NeuraMedica.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 315170 | 1189644150 | K213813 | DuraFuse Clip and Applier System | FZP | 2022-07-22 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FZP | 1 | 2022-07-22 |
2026-05-05
2023-05-15
2023-05-15
2023-05-15
2023-03-09
neuramedica.com