510(k) K253325
K253325 is an FDA 510(k) premarket notification submitted by Toetal Solutions for the device "ZipToe Hammertoe Fusion System". The FDA issued a decision of Substantially Equivalent on December 29, 2025. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2025
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type