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FDA 510(k)

Univers Revers Modular Glenoid System (Augemented baseplates)

K-Number: K193372 · 2020-01-10

ApplicantArthrex, Inc.
Decision Date2020-01-10
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Univers Revers Modular Glenoid System (Augemented baseplates) is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K193372. 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 Univers Revers Modular Glenoid System (Augemented baseplates)?

Univers Revers Modular Glenoid System (Augemented baseplates) is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Arthrex, Inc.. The 510(k) number is K193372.

When did Univers Revers Modular Glenoid System (Augemented baseplates) receive FDA 510(k) clearance?

Univers Revers Modular Glenoid System (Augemented baseplates) received FDA 510(k) clearance on 2020-01-10, under 510(k) number K193372.

Who is the listed applicant for Univers Revers Modular Glenoid System (Augemented baseplates)?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Univers Revers Modular Glenoid System (Augemented baseplates)?

The FDA product code for Univers Revers Modular Glenoid System (Augemented baseplates) is PHX.

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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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