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FDA 510(k)

FX V135(TM) Shoulder Prosthesis

K-Number: K223801 · 2023-06-05

ApplicantFx Shoulder USA, Inc.
Decision Date2023-06-05
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FX V135(TM) Shoulder Prosthesis is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2023-06-05 under approval number K223801. 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 FX V135(TM) Shoulder Prosthesis?

FX V135(TM) Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K223801.

When was FX V135(TM) Shoulder Prosthesis approved by the FDA?

FX V135(TM) Shoulder Prosthesis received FDA 510(k) clearance on 2023-06-05, under approval number K223801.

What company makes FX V135(TM) Shoulder Prosthesis?

FX V135(TM) Shoulder Prosthesis is manufactured by Fx Shoulder USA, Inc..

What is the FDA product code for FX V135(TM) Shoulder Prosthesis?

The FDA product code for FX V135(TM) Shoulder Prosthesis is PHX.

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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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