FDA 510(k)

Idys™ TLIF TiVac

K-Number: K183259 · 2019-03-01

Decision Date2019-03-01

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Idys™ TLIF TiVac is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183259. 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™ TLIF TiVac?

Idys™ TLIF TiVac is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Clariance, Sas. The 510(k) number is K183259.

When did Idys™ TLIF TiVac receive FDA 510(k) clearance?

Idys™ TLIF TiVac received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183259.

Who is the listed applicant for Idys™ TLIF TiVac?

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™ TLIF TiVac?

The FDA product code for Idys™ TLIF TiVac is MAX.

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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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.