K-number	K212710
Device name	GLOBAL UNITE Platform Shoulder System
Applicant	Depuy Ireland UC
Product code	PHX
Device class	Class II
Decision date	Sep 15, 2021
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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GLOBAL UNITE Platform Shoulder System

Everything you need for a 510(k) submission. Nothing you don't.

GLOBAL UNITE Platform Shoulder System