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FDA 510(k)

Arthrex Pilon Fusion System

K-Number: K203294 · 2021-02-03

ApplicantArthrex, Inc.
Decision Date2021-02-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Pilon Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K203294. 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 Pilon Fusion System?

Arthrex Pilon Fusion System is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K203294.

When did Arthrex Pilon Fusion System receive FDA 510(k) clearance?

Arthrex Pilon Fusion System received FDA 510(k) clearance on 2021-02-03, under 510(k) number K203294.

Who is the listed applicant for Arthrex Pilon Fusion System?

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 Pilon Fusion System?

The FDA product code for Arthrex Pilon Fusion System 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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