Data / Medical devices / United States / Auxano Medical LLC
Auxano Medical LLC: FDA-registered device maker in Brecksville, OH, United States, 2 510(k) clearances
Auxano Medical LLC is registered with the FDA (registration 3030271054) in Brecksville, OH, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030271054
- Address
- 8006 Katherine Boulevard, Brecksville, OH, United States, 44141
- Owner or operator
- Auxano Medical LLC (10089779)
- Roles
- Specification developer
- First device listed
- January 8, 2024
- Registered through
- 2026
- Brand names listed
- ARKEO, INTREPED, INTREPED Extraction Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Wedge | PLF | 2 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
| Trephine | HWK | 1 | 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 |
|---|---|---|---|---|---|---|
| September 25, 2025 | K251791 | Auxano® Wedge Fixation System | PLF | Substantially Equivalent | Auxano Medical, LLC | accessdata.fda.gov |
| September 29, 2023 | K231649 | Intraosseous Fusion Device System | HWC | Substantially Equivalent | Auxano Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 25, 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.