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FDA 510(k)

Arthrex DynaNite K-Wire

K-Number: K200068 · 2020-06-29

ApplicantArthrex, Inc.
Decision Date2020-06-29
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite K-Wire is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-06-29 under approval number K200068. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex DynaNite K-Wire?

Arthrex DynaNite K-Wire is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Arthrex, Inc.. The 510(k) number is K200068.

When was Arthrex DynaNite K-Wire approved by the FDA?

Arthrex DynaNite K-Wire received FDA 510(k) clearance on 2020-06-29, under approval number K200068.

What company makes Arthrex DynaNite K-Wire?

Arthrex DynaNite K-Wire is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex DynaNite K-Wire?

The FDA product code for Arthrex DynaNite K-Wire is HTY.

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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.