NervAlign Nerve Cuff
Renerve Ltd
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022317591 | 3022317591 | RENERVE LTD | 1 | N | 2026-01-01 | L 10 99 Queen Street Melbourne Victoria AU 3000 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 09369998075812 | NervAlign Nerve Cuff - An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity. | +16122938673 | customerserviceUS@nervalign.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 304388 | 1626090135 | K202234 | NervAlign Nerve Cuff | JXI | 2022-02-10 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JXI | 1 | 2022-02-10 |
Renerve Ltd
2022-04-08
2022-04-08
2022-04-08