GLOBAL UNITE™ Platform Shoulder System

Shoulder Prosthesis, Reverse Configuration

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Global Unite™ Platform Shoulder System.

Pre-market Notification Details

Device IDK212710
510k NumberK212710
Device Name:GLOBAL UNITE™ Platform Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DePuy Ireland UC Loughbeg Ringaskiddy Co. Cork Munster,  IE
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
DePuy Mitek, Inc. 325 Paramount Drive Raynham,  MA  02767
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-26
Decision Date2021-09-15

Trademark Results [GLOBAL UNITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLOBAL UNITE
GLOBAL UNITE
85031209 4183731 Live/Registered
DePuy Synthes, Inc.
2010-05-05

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