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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 K203694
Device Name DELTA XTEND Reverse Shoulder System
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Jaclyn Cincotta
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Jaclyn Cincotta
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received12/18/2020
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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