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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 K120174
Device Name DEPUT DELTA XTEND REVERSE SHOULDER
Applicant
DEPUY FRANCE
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46580
Applicant Contact MEGAN BURNS
Correspondent
DEPUY FRANCE
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46580
Correspondent Contact MEGAN BURNS
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received01/20/2012
Decision Date 06/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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