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FDA 510(k)

Humeral Cup Stability & Humeral Cup 135/145o Stability

K-Number: K193394 · 2020-04-29

ApplicantFx Shoulder USA, Inc.
Decision Date2020-04-29
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeral Cup Stability & Humeral Cup 135/145o Stability is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-04-29 under approval number K193394. 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 Humeral Cup Stability & Humeral Cup 135/145o Stability?

Humeral Cup Stability & Humeral Cup 135/145o Stability is a medical device that received FDA 510(k) clearance on 2020-04-29. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K193394.

When was Humeral Cup Stability & Humeral Cup 135/145o Stability approved by the FDA?

Humeral Cup Stability & Humeral Cup 135/145o Stability received FDA 510(k) clearance on 2020-04-29, under approval number K193394.

What company makes Humeral Cup Stability & Humeral Cup 135/145o Stability?

Humeral Cup Stability & Humeral Cup 135/145o Stability is manufactured by Fx Shoulder USA, Inc..

What is the FDA product code for Humeral Cup Stability & Humeral Cup 135/145o Stability?

The FDA product code for Humeral Cup Stability & Humeral Cup 135/145o Stability is PHX.

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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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