Oxiplex - Absorbable gel for spine surgery
2025-09-11
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2031637 | 3004474407 | FZIOMED, INC. | 1 | N | 2026-01-01 | 231 BONETTI DR San Luis Obispo CA US 93401 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00854395004507 | Oxiplex - Absorbable gel for spine surgery | 8055460610 | regulatory@fziomed.com |
| 10854395004504 | Oxiplex - Absorbable gel for spine surgery | 8055460610 | regulatory@fziomed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 55170 | 1805834934 | K253326 | Oxiplex | QVL | 2026-05-01 |
| 55170 | 1867262449 | DEN240038 | Oxiplex® | QVL | 2025-06-17 |
| 55170 | 1375026906 | ||||
| 55170 | 1802126750 | ||||
| 55170 | 2046682888 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QVL | 2 | 2026-05-01 |