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FDA 510(k)

EndoLIF Delta-Cage and DoubleWedge-Cage

K-Number: K203014 · 2021-09-01

ApplicantJoimax GmbH
Decision Date2021-09-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EndoLIF Delta-Cage and DoubleWedge-Cage is the device name listed in this FDA 510(k) record. The listed applicant is Joimax GmbH. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K203014. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoLIF Delta-Cage and DoubleWedge-Cage?

EndoLIF Delta-Cage and DoubleWedge-Cage is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Joimax GmbH. The 510(k) number is K203014.

When did EndoLIF Delta-Cage and DoubleWedge-Cage receive FDA 510(k) clearance?

EndoLIF Delta-Cage and DoubleWedge-Cage received FDA 510(k) clearance on 2021-09-01, under 510(k) number K203014.

Who is the listed applicant for EndoLIF Delta-Cage and DoubleWedge-Cage?

The FDA 510(k) record lists Joimax GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoLIF Delta-Cage and DoubleWedge-Cage?

The FDA product code for EndoLIF Delta-Cage and DoubleWedge-Cage is MAX.

Other records listing Joimax GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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