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Alevio, LLC

FDA Regulatory Profile

Alevio, LLC has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 10, 2021 · NAI
Latest 510(k)
Jul 28, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 10, 2021Cullman, ALBiologicsNo Action Indicated (NAI)3012249461
Dec 15, 2016Cullman, ALDevicesNo Action Indicated (NAI)3012249461

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K231951SI-Cure Sacroiliac Joint Fusion SystemJul 28, 2023
K223819SI-Cure Sacroiliac Joint Fusion SystemJan 18, 2023

FDA data resources