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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 K210167
Device Name DELTA XTEND Reverse Shoulder System
Applicant
DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Applicant Contact Megan Bernier
Correspondent
DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Megan Bernier
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received01/21/2021
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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