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 a medical device manufactured by Clariance, Sas. It received FDA 510(k) clearance on 2019-03-01 under approval 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. It is manufactured by Clariance, Sas. The 510(k) number is K183259.

When was Idys TLIF TiVac approved by the FDA?

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

What company makes Idys TLIF TiVac?

Idys TLIF TiVac is manufactured by Clariance, Sas.

What is the FDA product code for Idys TLIF TiVac?

The FDA product code for Idys TLIF TiVac is MAX.

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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.