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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K190287.

When did Arthrex DynaNite® PIP (Hammertoe) Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex DynaNite® PIP (Hammertoe) Implant?

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® PIP (Hammertoe) Implant?

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

Other records listing Arthrex, Inc. as applicant

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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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