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Joimax GmbH

FDA Regulatory Profile

Joimax GmbH has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 4, 2018 · VAI
Latest 510(k)
Sep 1, 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) clearances7Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 4, 2018Karlsruhe, GermanyDevicesVoluntary Action Indicated (VAI)3005083075

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
K203014EndoLIF Delta-Cage and DoubleWedge-CageSep 1, 2021
K192663Joimax Intracs SystemJul 30, 2020
K192680Percusys® Plus Pedicle Screw SystemDec 18, 2019
K170358joimax Endovapor 2Apr 21, 2017
K161378joimax Electrosurgical InstrumentsNov 2, 2016
K151143EndoLIF On-CageJul 9, 2015
K051827JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPEAug 12, 2005

FDA data resources