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FDA 510(k)

GLOBAL UNITE Platform Shoulder System

K-Number: K170748 · 2018-01-11

ApplicantDepuy Ireland UC
Decision Date2018-01-11
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL UNITE Platform Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K170748. 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 GLOBAL UNITE Platform Shoulder System?

GLOBAL UNITE Platform Shoulder System is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Depuy Ireland UC. The 510(k) number is K170748.

When did GLOBAL UNITE Platform Shoulder System receive FDA 510(k) clearance?

GLOBAL UNITE Platform Shoulder System received FDA 510(k) clearance on 2018-01-11, under 510(k) number K170748.

Who is the listed applicant for GLOBAL UNITE Platform Shoulder System?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL UNITE Platform Shoulder System?

The FDA product code for GLOBAL UNITE Platform Shoulder System 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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