Data / Medical devices / United States / Toetal Solutions, Inc
Toetal Solutions, Inc: FDA-registered device maker in Malvern, PA, United States, 1 510(k) clearance
Toetal Solutions, Inc is registered with the FDA (registration 3026032087) in Malvern, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026032087
- Address
- 7 Great Valley Pkwy Ste 295, Malvern, PA, United States, 19355
- Owner or operator
- Toetal Solutions, Inc (10095176)
- Roles
- Specification developer
- First device listed
- February 3, 2026
- Registered through
- 2026
- Brand names listed
- ZipToe Hammertoe Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | K253325 | ZipToe Hammertoe Fusion System | HTY | Substantially Equivalent | Toetal Solutions | accessdata.fda.gov |
Compare with other makers
Updated December 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.