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FDA 510(k)

Humeris Shoulder

K-Number: K163669 · 2017-05-17

ApplicantFx Solutions
Decision Date2017-05-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeris Shoulder is a medical device manufactured by Fx Solutions. It received FDA 510(k) clearance on 2017-05-17 under approval number K163669. 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 Humeris Shoulder?

Humeris Shoulder is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Fx Solutions. The 510(k) number is K163669.

When was Humeris Shoulder approved by the FDA?

Humeris Shoulder received FDA 510(k) clearance on 2017-05-17, under approval number K163669.

What company makes Humeris Shoulder?

Humeris Shoulder is manufactured by Fx Solutions.

What is the FDA product code for Humeris Shoulder?

The FDA product code for Humeris Shoulder is PHX.

Other Devices by Fx Solutions

K162455Humelock Reversed Shoulder

Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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