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Axis Spine Technologies, Ltd.

FDA Regulatory Profile

Axis Spine Technologies, Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 21, 2024 · VAI
Latest 510(k)
Sep 29, 2021

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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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 21, 2024Leeds, United KingdomDevicesVoluntary Action Indicated (VAI)3016668776

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
K210590Axis Spine Technologies ALIFSep 29, 2021
K200352Axis Spine Technologies ALIFMay 20, 2020

FDA data resources