K251791
- 510(k) number
- K251791
- Device name
- Auxano® Wedge Fixation System
- Applicant
- Auxano Medical, LLC OH · US
- Product code
- PLF — Bone Wedge
- Decision date
- 2025-09-25
- Date received
- 2025-06-11
- 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: K251791.pdf
Official FDA record: K251791
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.