K251075
- 510(k) number
- K251075
- Device name
- DYNAMIS Implant System
- Applicant
- Promethean Restorative, LLC CO · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-04-25
- Date received
- 2025-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251075.pdf
Official FDA record: K251075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.