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Data / Medical devices / United States / Joimax, Inc.

Joimax, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance

Joimax, Inc. is registered with the FDA (registration 3005042595) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3005042595
Address
140 Technology Drive, Suite 150, Irvine, CA, United States, 92618
Owner or operator
Joimax GmbH (9070895)
Roles
Complaint file establishment
First device listed
November 17, 2021
Registered through
2026
Brand names listed
EndoLIF(R) Delta-Cage, EndoLIF(R) DoubleWedge-Cage

Devices it lists

DeviceProduct codeClassRoleSource
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 1, 2021K203014EndoLIF Delta-Cage and DoubleWedge-CageMAXSubstantially EquivalentJoimax GmbHaccessdata.fda.gov

Compare with other makers

Updated September 1, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.