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Keos

FDA Regulatory Profile

Keos has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 11, 2023 · NAI
Latest 510(k)
Jun 6, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 11, 2023Lancaster, PADevicesNo Action Indicated (NAI)3013921069
Aug 23, 2019Lancaster, PADevicesVoluntary Action Indicated (VAI)3013921069

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
K212450Keos Anterior Cervical Interbody Fusion Device SystemJun 6, 2022
K193174Keos Lumbar IBFDDec 16, 2019
K163386Keos Lumbar IBFDApr 10, 2017
K160631Keos Lumbar IBFDJul 15, 2016

FDA data resources