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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K170748
Device Name GLOBAL UNITE Platform Shoulder System
Applicant
DePuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Carol Sandberg Ming
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Kellie Myers
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received03/10/2017
Decision Date 01/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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