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FDA 510(k)

Arthrex Eclipse Shoulder Prosthesis System

K-Number: K183194 · 2019-07-26

ApplicantArthrex, Inc.
Decision Date2019-07-26
Product CodeQHQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Eclipse Shoulder Prosthesis 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 2019-07-26 under 510(k) number K183194. The device is classified under product code QHQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Eclipse Shoulder Prosthesis System?

Arthrex Eclipse Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Arthrex, Inc.. The 510(k) number is K183194.

When did Arthrex Eclipse Shoulder Prosthesis System receive FDA 510(k) clearance?

Arthrex Eclipse Shoulder Prosthesis System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K183194.

Who is the listed applicant for Arthrex Eclipse Shoulder Prosthesis 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 Eclipse Shoulder Prosthesis System?

The FDA product code for Arthrex Eclipse Shoulder Prosthesis System is QHQ.

Other records listing Arthrex, Inc. as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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