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Adcura, Inc.

FDA Regulatory Profile

Adcura, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
May 23, 2025 · NAI
Latest 510(k)
Oct 26, 2022

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 23, 2025Wayzata, MNDevicesNo Action Indicated (NAI)3013758617
Mar 2, 2022Wayzata, MNDevicesNo Action Indicated (NAI)3013758617
Dec 12, 2017Wayzata, MNDevicesNo Action Indicated (NAI)3013758617

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
K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesOct 26, 2022

FDA data resources