K233241
- 510(k) number
- K233241
- Device name
- SOLACE Sacroiliac Fixation System
- Applicant
- Ht Medical, LLC Dba Xenix Medical FL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2023-10-27
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233241.pdf
Official FDA record: K233241
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.