Data / Medical devices / United States / Alevio, LLC
Alevio, LLC: FDA-registered device maker in Cullman, AL, United States, 2 510(k) clearances
Alevio, LLC is registered with the FDA (registration 3012249461) in Cullman, AL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012249461
- Address
- 17721 Us Highway 31, Cullman, AL, United States, 35058
- Owner or operator
- ALEVIO, LLC (10051119)
- Roles
- Manufacturer
- First device listed
- February 25, 2025
- Registered through
- 2026
- Brand names listed
- SI-CURE SACROILIAC JOINT FUSION SYSTEM, SI-CURE: FOUNDATION, SACROILIAC JOINT FUSION SYSTEM, SI-CURE: MICRO, SACROILIAC JOINT FUSION SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 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 |
|---|---|---|---|---|---|---|
| July 28, 2023 | K231951 | SI-Cure Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | Alevio, LLC | accessdata.fda.gov |
| January 18, 2023 | K223819 | SI-Cure Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | Alevio, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 28, 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.