FDA 510(k)

Aequalis Fx2

K-Number: K152966 · 2016-01-14

Decision Date2016-01-14

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Aequalis Fx2 is a medical device manufactured by Tornier S.A.S.. It received FDA 510(k) clearance on 2016-01-14 under approval number K152966. 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 Fx2?

Aequalis Fx2 is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Tornier S.A.S.. The 510(k) number is K152966.

When was Aequalis Fx2 approved by the FDA?

Aequalis Fx2 received FDA 510(k) clearance on 2016-01-14, under approval number K152966.

What company makes Aequalis Fx2?

Aequalis Fx2 is manufactured by Tornier S.A.S..

What is the FDA product code for Aequalis Fx2?

The FDA product code for Aequalis Fx2 is PHX.

Other Devices by Tornier S.A.S.

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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 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.