K241813
- 510(k) number
- K241813
- Device name
- SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- Applicant
- Si-Technology, LLC CO · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-08-13
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241813.pdf
Official FDA record: K241813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.