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FDA 510(k)

Arthrex DynaNite Compression Plate

K-Number: K193345 · 2020-07-08

ApplicantArthrex, Inc.
Decision Date2020-07-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex DynaNite Compression Plate is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-07-08 under approval number K193345. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex DynaNite Compression Plate?

Arthrex DynaNite Compression Plate is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Arthrex, Inc.. The 510(k) number is K193345.

When was Arthrex DynaNite Compression Plate approved by the FDA?

Arthrex DynaNite Compression Plate received FDA 510(k) clearance on 2020-07-08, under approval number K193345.

What company makes Arthrex DynaNite Compression Plate?

Arthrex DynaNite Compression Plate is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex DynaNite Compression Plate?

The FDA product code for Arthrex DynaNite Compression Plate is HRS.

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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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