K232149 is an FDA 510(k) clearance for the BowTie™ SI Joint Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Sail Fusion, LLC (Del Mar, US). The FDA issued a Cleared decision on April 20, 2024, 276 days after receiving the submission on July 19, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K232149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2023 |
| Decision Date | April 20, 2024 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OUR - Sacroiliac Joint Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Sacroiliac Joint Fusion |