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FDA 510(k)

Arthrex Modular Glenoid System-Titanium Glenosphere

K-Number: K212415 · 2021-11-17

ApplicantArthrex, Inc.
Decision Date2021-11-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Modular Glenoid System-Titanium Glenosphere is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K212415. 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 Arthrex Modular Glenoid System-Titanium Glenosphere?

Arthrex Modular Glenoid System-Titanium Glenosphere is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Arthrex, Inc.. The 510(k) number is K212415.

When did Arthrex Modular Glenoid System-Titanium Glenosphere receive FDA 510(k) clearance?

Arthrex Modular Glenoid System-Titanium Glenosphere received FDA 510(k) clearance on 2021-11-17, under 510(k) number K212415.

Who is the listed applicant for Arthrex Modular Glenoid System-Titanium Glenosphere?

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 Arthrex Modular Glenoid System-Titanium Glenosphere?

The FDA product code for Arthrex Modular Glenoid System-Titanium Glenosphere 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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