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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-06-29 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K200068.

When did Arthrex DynaNite K-Wire receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex DynaNite K-Wire?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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