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FDA 510(k)

Idys ALIF 3DTi

K-Number: K200919 · 2021-04-12

ApplicantClariance
Decision Date2021-04-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Idys ALIF 3DTi is a medical device manufactured by Clariance. It received FDA 510(k) clearance on 2021-04-12 under approval number K200919. 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 Idys ALIF 3DTi?

Idys ALIF 3DTi is a medical device that received FDA 510(k) clearance on 2021-04-12. It is manufactured by Clariance. The 510(k) number is K200919.

When was Idys ALIF 3DTi approved by the FDA?

Idys ALIF 3DTi received FDA 510(k) clearance on 2021-04-12, under approval number K200919.

What company makes Idys ALIF 3DTi?

Idys ALIF 3DTi is manufactured by Clariance.

What is the FDA product code for Idys ALIF 3DTi?

The FDA product code for Idys ALIF 3DTi is MAX.

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Related Devices (Code: MAX)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.