Data / Medical devices / United States / Ortho Outcomes, LLC
Ortho Outcomes, LLC: FDA-registered device maker in Salt Lake City, UT, United States, 1 510(k) clearance
Ortho Outcomes, LLC is registered with the FDA (registration 3035373797) in Salt Lake City, UT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035373797
- Address
- 2490 S 300 W, Salt Lake City, UT, United States, 84115
- Owner or operator
- Ortho Outcomes, LLC (10092508)
- Roles
- Specification developer
- First device listed
- January 15, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 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 |
|---|---|---|---|---|---|---|
| June 26, 2023 | K230867 | Bone Bolt System | HWC | Substantially Equivalent | University of Utah, Department of Orthopaedics | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2023. 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.