FDA 510(k)

FiberTak DR

K-Number: K160319 · 2016-05-10

Decision Date2016-05-10

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FiberTak DR is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-05-10 under approval number K160319. 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 DR?

FiberTak DR is a medical device that received FDA 510(k) clearance on 2016-05-10. It is manufactured by Arthrex, Inc.. The 510(k) number is K160319.

When was FiberTak DR approved by the FDA?

FiberTak DR received FDA 510(k) clearance on 2016-05-10, under approval number K160319.

What company makes FiberTak DR?

FiberTak DR is manufactured by Arthrex, Inc..

What is the FDA product code for FiberTak DR?

The FDA product code for FiberTak DR is MBI.

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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.