K250647
- 510(k) number
- K250647
- Device name
- SImmetry+ System
- Applicant
- Sivantage FL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-07-29
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250647.pdf
Official FDA record: K250647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.