Data / Medical devices / United States / Mentor Supply Chain (usa) Inc
Mentor Supply Chain (usa) Inc: FDA-registered device maker in Warsaw, IN, United States, 1 510(k) clearance
Mentor Supply Chain (usa) Inc is registered with the FDA (registration 3027848094) in Warsaw, IN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027848094
- Address
- 1395 Polk Drive, Warsaw, IN, United States, 46582
- Owner or operator
- MENTOR SUPPLY CHAIN (USA) INC (10089103)
- Roles
- Repackager or relabeler
- First device listed
- November 6, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 11, 2018 | K172205 | ExoToe Staple | JDR | Substantially Equivalent | Exotoe, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 11, 2018. 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.