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FDA 510(k)

Glenoid Reconstruction System

K-Number: K213459 · 2022-11-23

ApplicantMedacta International S.A.
Decision Date2022-11-23
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Glenoid Reconstruction System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-11-23 under approval number K213459. 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 Glenoid Reconstruction System?

Glenoid Reconstruction System is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Medacta International S.A.. The 510(k) number is K213459.

When was Glenoid Reconstruction System approved by the FDA?

Glenoid Reconstruction System received FDA 510(k) clearance on 2022-11-23, under approval number K213459.

What company makes Glenoid Reconstruction System?

Glenoid Reconstruction System is manufactured by Medacta International S.A..

What is the FDA product code for Glenoid Reconstruction System?

The FDA product code for Glenoid Reconstruction System is PHX.

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Other Devices by Medacta International S.A.

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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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