K232149
- 510(k) number
- K232149
- Device name
- BowTie SI Joint Fusion System
- Applicant
- Sail Fusion, LLC CA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-04-20
- Date received
- 2023-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232149.pdf
Official FDA record: K232149
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.