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FDA 510(k)

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

K-Number: K161742 · 2016-11-15

ApplicantTornier, Inc.
Decision Date2016-11-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2016-11-15 under approval number K161742. 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 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Tornier, Inc.. The 510(k) number is K161742.

When was Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid approved by the FDA?

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid received FDA 510(k) clearance on 2016-11-15, under approval number K161742.

What company makes Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is manufactured by Tornier, Inc..

What is the FDA product code for Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

The FDA product code for Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is PHX.

Other Devices by Tornier, Inc.

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Related Devices (Code: PHX)

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. K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.

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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