FUSION INNOVATIONS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019923333 | 3019923333 | FUSION INNOVATIONS | 1 | N | 2026-01-01 | 341 N. Maitland Ave #270 Maitland FL US 32751 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 307218 | 1761040678 | K252661 | SternaFuse Ti Fixation System | HRS | 2025-11-19 |
| 307218 | 1735456240 | K202914 | SternaFuse Fixation System | HRS | 2022-01-26 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRS | 2 | 2025-11-19 |