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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-07-08 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K193345.

When did Arthrex DynaNite Compression Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex DynaNite Compression Plate?

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 Compression Plate?

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

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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