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FDA 510(k)

Arthrex Univers Revers Apex Humeral Stems

K-Number: K170414 · 2017-12-14

ApplicantArthrex, Inc.
Decision Date2017-12-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Apex Humeral Stems is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-12-14 under approval number K170414. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Univers Revers Apex Humeral Stems?

Arthrex Univers Revers Apex Humeral Stems is a medical device that received FDA 510(k) clearance on 2017-12-14. It is manufactured by Arthrex, Inc.. The 510(k) number is K170414.

When was Arthrex Univers Revers Apex Humeral Stems approved by the FDA?

Arthrex Univers Revers Apex Humeral Stems received FDA 510(k) clearance on 2017-12-14, under approval number K170414.

What company makes Arthrex Univers Revers Apex Humeral Stems?

Arthrex Univers Revers Apex Humeral Stems is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers Apex Humeral Stems?

The FDA product code for Arthrex Univers Revers Apex Humeral Stems is PHX.

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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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