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Sign in to claim this brandSAIL FUSION
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2010 Jimmy Durante Blvd Ste 200, Del Mar, CA, 92014
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3031024716
- DUNS Number
- —
Catalogue (57)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BowTie SI Fusion System | 90-JFB-300100 | FDA UDI | Class I | Active |
| BowTie SI Fusion System | 90-JFB-200340 | FDA UDI | Class I | Active |
| BowTie SI Fusion System | 90-JFB-300400 | FDA UDI | Class I | Active |
| BowTie SI Fusion System | 90-JFA-200060 | FDA UDI | Class II | Active |
| BowTie SI Fusion System | 90-JFA-100045 | FDA UDI | Class II | Active |
| BowTie SI Fusion System | 90-JFA-200100 | FDA UDI | Class II | Active |
| BowTie™ SI Joint Fusion System | K232149 | FDA 510(k) | Class II | Active |
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