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FDA 510(k)

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres

K-Number: K213124 · 2021-10-26

ApplicantTornier, Inc.
Decision Date2021-10-26
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2021-10-26 under approval number K213124. 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 Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by Tornier, Inc.. The 510(k) number is K213124.

When was Tomier Perform™ Reversed Glenoid Cannulated Glenospheres approved by the FDA?

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres received FDA 510(k) clearance on 2021-10-26, under approval number K213124.

What company makes Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is manufactured by Tornier, Inc..

What is the FDA product code for Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

The FDA product code for Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is PHX.

Other Devices by Tornier, Inc.

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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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