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FDA 510(k)

Arthrex Eclipse Shoulder Prosthesis System

K-Number: K201542 · 2020-07-08

ApplicantArthrex, Inc.
Decision Date2020-07-08
Product CodePKC
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 2020-07-08 under 510(k) number K201542. The device is classified under product code PKC. 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 2020-07-08. The listed applicant is Arthrex, Inc.. The 510(k) number is K201542.

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

Arthrex Eclipse Shoulder Prosthesis System received FDA 510(k) clearance on 2020-07-08, under 510(k) number K201542.

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 PKC.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: PKC)

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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

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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