SAIL FUSION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3031024716 | 3031024716 | SAIL FUSION | 1 | N | 2026-01-01 | 2010 Jimmy Durante Blvd Ste 200 Del Mar CA US 92014 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 336105 | 1616393087 | K232149 | BowTie™ SI Joint Fusion System | OUR | 2024-04-20 |
| 336105 | 1363881170 | ||||
| 336105 | 1512392139 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OUR | 1 | 2024-04-20 |