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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2021-11-04 under 510(k) 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. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K211729.

When did Comprehensive® Convertible Glenoid - Vivacit-E Liner receive FDA 510(k) clearance?

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

Who is the listed applicant for Comprehensive® Convertible Glenoid - Vivacit-E Liner?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Biomet Manufacturing Corp as applicant

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Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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