FDA 510(k)

Arthrex Tenodesis Button

K-Number: K190288 · 2019-09-13

Decision Date2019-09-13

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex Tenodesis Button is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K190288. 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 Arthrex Tenodesis Button?

Arthrex Tenodesis Button is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Arthrex, Inc.. The 510(k) number is K190288.

When was Arthrex Tenodesis Button approved by the FDA?

Arthrex Tenodesis Button received FDA 510(k) clearance on 2019-09-13, under approval number K190288.

What company makes Arthrex Tenodesis Button?

Arthrex Tenodesis Button is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Tenodesis Button?

The FDA product code for Arthrex Tenodesis Button 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.