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 IDK170748
510k NumberK170748
Device Name:GLOBAL UNITE Platform Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DePuy Ireland UC Loughbeg Ringaskiddy,  IE
ContactCarol Sandberg Ming
CorrespondentKellie Myers
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw,  IN  46582
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-10
Decision Date2018-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295116592 K170748 000
10603295116097 K170748 000
10603295116080 K170748 000
10603295116066 K170748 000
10603295116059 K170748 000
10603295116042 K170748 000
10603295116035 K170748 000
10603295116028 K170748 000
10603295164661 K170748 000
10603295446682 K170748 000
10603295446675 K170748 000
10603295116103 K170748 000
10603295116110 K170748 000
10603295116523 K170748 000
10603295116448 K170748 000
10603295116349 K170748 000
10603295116189 K170748 000
10603295116172 K170748 000
10603295116165 K170748 000
10603295116158 K170748 000
10603295116141 K170748 000
10603295116134 K170748 000
10603295116127 K170748 000
10603295444749 K170748 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.