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FDA 510(k)

Arthrex DynaNite® PIP (Hammertoe) Implant

K-Number: K190287 · 2019-05-03

ApplicantArthrex, Inc.
Decision Date2019-05-03
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite® PIP (Hammertoe) Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval number K190287. 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® PIP (Hammertoe) Implant?

Arthrex DynaNite® PIP (Hammertoe) Implant is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Arthrex, Inc.. The 510(k) number is K190287.

When was Arthrex DynaNite® PIP (Hammertoe) Implant approved by the FDA?

Arthrex DynaNite® PIP (Hammertoe) Implant received FDA 510(k) clearance on 2019-05-03, under approval number K190287.

What company makes Arthrex DynaNite® PIP (Hammertoe) Implant?

Arthrex DynaNite® PIP (Hammertoe) Implant is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex DynaNite® PIP (Hammertoe) Implant?

The FDA product code for Arthrex DynaNite® PIP (Hammertoe) Implant 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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