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FDA 510(k)

Arthrex Univers Revers Monoblock Stem Size 4/33

K-Number: K230366 · 2023-04-10

ApplicantArthrex, Inc.
Decision Date2023-04-10
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Monoblock Stem Size 4/33 is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-04-10 under approval number K230366. 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 Monoblock Stem Size 4/33?

Arthrex Univers Revers Monoblock Stem Size 4/33 is a medical device that received FDA 510(k) clearance on 2023-04-10. It is manufactured by Arthrex, Inc.. The 510(k) number is K230366.

When was Arthrex Univers Revers Monoblock Stem Size 4/33 approved by the FDA?

Arthrex Univers Revers Monoblock Stem Size 4/33 received FDA 510(k) clearance on 2023-04-10, under approval number K230366.

What company makes Arthrex Univers Revers Monoblock Stem Size 4/33?

Arthrex Univers Revers Monoblock Stem Size 4/33 is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers Monoblock Stem Size 4/33?

The FDA product code for Arthrex Univers Revers Monoblock Stem Size 4/33 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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