K240505
- 510(k) number
- K240505
- Device name
- Eminent Spine SI Screw System
- Applicant
- Eminent Spine, LLC TX · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-06-04
- Date received
- 2024-02-21
- 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: K240505.pdf
Official FDA record: K240505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.