K253325
- 510(k) number
- K253325
- Device name
- ZipToe Hammertoe Fusion System
- Applicant
- Toetal Solutions PA · US
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2025-12-29
- Date received
- 2025-09-30
- 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: K253325.pdf
Official FDA record: K253325
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.