FDA 510(k) K232149, BowTie™ SI Joint Fusion System, by Sail Fusion, LLC
FDA 510(k) K232149, BowTie™ SI Joint Fusion System, by Sail Fusion, LLC
| 510(k) Number | K232149 |
| Device Classification Name | Sacroiliac Joint Fixation |
| Device Name | BowTie™ SI Joint Fusion System |
| Applicant | Sail Fusion, LLC 2010 Jimmy Durante Blvd., Suite 200 Del Mar, CA 92014 |
| Regulation Number | 888.304 |
| Classification Product Code | OUR |
| Date Received | 07/19/2023 |
| Decision Date | 04/20/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Orthopedic |
| 510k Review Panel | Orthopedic |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 3361 |
| Redacted Pages | 3064 |
| Unredacted Pages | 297 |
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