FDA 510(k)

Integra TITAN Reverse Shoulder System

K-Number: K161189 · 2016-08-25

ApplicantIntegra LifeSciences Corporation

Decision Date2016-08-25

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Integra TITAN Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161189. 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 2016-08-25. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K161189.

When did Integra TITAN Reverse Shoulder System receive FDA 510(k) clearance?

Integra TITAN Reverse Shoulder System received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161189.

Who is the listed applicant for Integra TITAN Reverse Shoulder System?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

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)

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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.