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FDA 510(k)

Tornier Perform Humeral System – Fracture

K-Number: K220914 · 2022-10-14

ApplicantTornier, Inc.
Decision Date2022-10-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Perform Humeral System – Fracture is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2022-10-14 under approval number K220914. 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 Tornier Perform Humeral System – Fracture?

Tornier Perform Humeral System – Fracture is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Tornier, Inc.. The 510(k) number is K220914.

When was Tornier Perform Humeral System – Fracture approved by the FDA?

Tornier Perform Humeral System – Fracture received FDA 510(k) clearance on 2022-10-14, under approval number K220914.

What company makes Tornier Perform Humeral System – Fracture?

Tornier Perform Humeral System – Fracture is manufactured by Tornier, Inc..

What is the FDA product code for Tornier Perform Humeral System – Fracture?

The FDA product code for Tornier Perform Humeral System – Fracture is PHX.

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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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