K232211
- 510(k) number
- K232211
- Device name
- REUNION Sacroiliac Joint Fusion System
- Applicant
- Astura Medical TX · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2023-10-24
- Date received
- 2023-07-26
- 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: K232211.pdf
Official FDA record: K232211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.