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FDA 510(k)

Comprehensive® Convertible Glenoid - Vivacit-E Liner

K-Number: K211729 · 2021-11-04

ApplicantBiomet Manufacturing Corp
Decision Date2021-11-04
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive® Convertible Glenoid - Vivacit-E Liner is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2021-11-04 under approval number K211729. 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 Comprehensive® Convertible Glenoid - Vivacit-E Liner?

Comprehensive® Convertible Glenoid - Vivacit-E Liner is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K211729.

When was Comprehensive® Convertible Glenoid - Vivacit-E Liner approved by the FDA?

Comprehensive® Convertible Glenoid - Vivacit-E Liner received FDA 510(k) clearance on 2021-11-04, under approval number K211729.

What company makes Comprehensive® Convertible Glenoid - Vivacit-E Liner?

Comprehensive® Convertible Glenoid - Vivacit-E Liner is manufactured by Biomet Manufacturing Corp.

What is the FDA product code for Comprehensive® Convertible Glenoid - Vivacit-E Liner?

The FDA product code for Comprehensive® Convertible Glenoid - Vivacit-E Liner is PHX.

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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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