Amplify Surgical, Inc.

FDA Regulatory Profile

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

Latest inspection
Mar 8, 2022 · VAI
Latest 510(k)
Oct 18, 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
Mar 8, 2022Foothill Ranch, CADevicesVoluntary Action Indicated (VAI)3015255331

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
K222203DualXSLIM(R) T/PLIFOct 18, 2022
K211740DualXSep 29, 2021
K192434DualX Lumbar Intervertebral Body Fusion DeviceOct 15, 2019