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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K081620
Device Name MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact RHONDA MYER
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact RHONDA MYER
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received06/09/2008
Decision Date 06/30/2008
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
Recalls CDRH Recalls
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