K250251
- 510(k) number
- K250251
- Device name
- Eleganz Fusion Screw System (Fusion Screw System)
- Applicant
- Dev4 TX · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-06-13
- Date received
- 2025-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250251.pdf
Official FDA record: K250251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.