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FDA 510(k)

Arthrex Eclipse Titanium Humeral Head

K-Number: K203100 · 2020-11-20

ApplicantArthrex, Inc.
Decision Date2020-11-20
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Eclipse Titanium Humeral Head is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-11-20 under approval number K203100. 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 Titanium Humeral Head?

Arthrex Eclipse Titanium Humeral Head is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Arthrex, Inc.. The 510(k) number is K203100.

When was Arthrex Eclipse Titanium Humeral Head approved by the FDA?

Arthrex Eclipse Titanium Humeral Head received FDA 510(k) clearance on 2020-11-20, under approval number K203100.

What company makes Arthrex Eclipse Titanium Humeral Head?

Arthrex Eclipse Titanium Humeral Head is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Eclipse Titanium Humeral Head?

The FDA product code for Arthrex Eclipse Titanium Humeral Head is PKC.

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.

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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