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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 K183077
Device Name Delta Xtend Reverse Shoulder System
Applicant
DePuy (Ireland)
Loughbeg Ringaskiddy
Co. Cork Munster,  IE
Applicant Contact Yayoi Fujimaki
Correspondent
Depuy Orthopajedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Yayoi Fujimaki
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received11/05/2018
Decision Date 05/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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