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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 K192448
Device Name Delta Xtend Revers Shoulder System
Applicant
Depuy(Ireland)
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Ashley Goncalo
Correspondent
Depuy Orthopaedies, Inc.
700 Orthopaedies Dr.
Warsaw,  IN  46582
Correspondent Contact Ashley Goncalo
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
HSD  
Date Received09/06/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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