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FDA 510(k)

Integra TITAN Reverse Shoulder System

K-Number: K190588 · 2019-12-02

ApplicantIntegra LifeSciences Corporation
Decision Date2019-12-02
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integra TITAN Reverse Shoulder System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2019-12-02 under approval number K190588. 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 Integra TITAN Reverse Shoulder System?

Integra TITAN Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K190588.

When was Integra TITAN Reverse Shoulder System approved by the FDA?

Integra TITAN Reverse Shoulder System received FDA 510(k) clearance on 2019-12-02, under approval number K190588.

What company makes Integra TITAN Reverse Shoulder System?

Integra TITAN Reverse Shoulder System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Integra TITAN Reverse Shoulder System?

The FDA product code for Integra TITAN Reverse Shoulder System 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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