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Grafton Medical Alliance

FDA Regulatory Profile

Grafton Medical Alliance has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Oct 26, 2023 · NAI
Latest 510(k)
Nov 13, 2019

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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
Oct 26, 2023Burr Ridge, ILDevicesNo Action Indicated (NAI)3011195316
Aug 4, 2021Burr Ridge, ILDevicesNo Action Indicated (NAI)3011195316
Oct 30, 2015Burr Ridge, ILDevicesNo Action Indicated (NAI)3011195316

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
K192915GMA 2.0 Pedicle Screw SystemNov 13, 2019

FDA data resources