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FDA 510(k)

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay

K-Number: K182039 · 2018-09-28

ApplicantArthrex, Inc.
Decision Date2018-09-28
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K182039. 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 Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay?

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Arthrex, Inc.. The 510(k) number is K182039.

When did Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay receive FDA 510(k) clearance?

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay received FDA 510(k) clearance on 2018-09-28, under 510(k) number K182039.

Who is the listed applicant for Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay?

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 Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay?

The FDA product code for Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is PHX.

Related Clinical Trials

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.

NCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITING

Other records listing Arthrex, Inc. 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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