FDA 510(k)

FiberTak Button

K-Number: K191426 · 2019-11-26

Decision Date2019-11-26

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FiberTak Button is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K191426. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FiberTak Button?

FiberTak Button is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K191426.

When was FiberTak Button approved by the FDA?

FiberTak Button received FDA 510(k) clearance on 2019-11-26, under approval number K191426.

What company makes FiberTak Button?

FiberTak Button is manufactured by Arthrex, Inc..

What is the FDA product code for FiberTak Button?

The FDA product code for FiberTak Button is MBI.

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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.