K243565
- 510(k) number
- K243565
- Device name
- DYNAMIS SI Screw System
- Applicant
- Promethean Restorative, LLC CO · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-02-28
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243565.pdf
Official FDA record: K243565
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.