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FDA 510(k)

Idys LLIF 3DTi

K-Number: K202032 · 2021-04-01

ApplicantClariance, Sas
Decision Date2021-04-01
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Idys LLIF 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K202032. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idys LLIF 3DTi?

Idys LLIF 3DTi is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Clariance, Sas. The 510(k) number is K202032.

When did Idys LLIF 3DTi receive FDA 510(k) clearance?

Idys LLIF 3DTi received FDA 510(k) clearance on 2021-04-01, under 510(k) number K202032.

Who is the listed applicant for Idys LLIF 3DTi?

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

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

The FDA product code for Idys LLIF 3DTi is OVD.

Other records listing Clariance, Sas 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.

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Related Devices (Code: OVD)

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.

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Official Source

View on FDA Database →

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

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