Data / Medical devices / United States / Leith Medical LLC
Leith Medical LLC: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Leith Medical LLC is registered with the FDA (registration 3018077525) in Austin, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018077525
- Address
- 4705 Eagle Feather Dr, Austin, TX, United States, 78735
- Owner or operator
- Leith Medical Inc (10080791)
- Roles
- Manufacturer
- First device listed
- February 25, 2021
- Registered through
- 2026
- Brand names listed
- Leith Foot and Ankle system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 22, 2021 | K200062 | Foot and Ankle System | HRS | Substantially Equivalent | Leith Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 22, 2021. 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.