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Medynus, Inc.

FDA Regulatory Profile

Medynus, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 17, 2024 · NAI
Latest 510(k)
Mar 3, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 17, 2024Irvine, CADevicesNo Action Indicated (NAI)3015426608

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
K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMar 3, 2022
K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageSep 23, 2021
K210420Goblin and Goblin LS Pedicle Screw SystemsApr 19, 2021

FDA data resources