K250867
- 510(k) number
- K250867
- Device name
- Dunamis Screw and Suture Locking System
- Applicant
- Dunamis Medical, LLC AL · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-08-15
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250867.pdf
Official FDA record: K250867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.