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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 K203230
Device Name Global Shoulder and Delta CTA systems
Applicant
DePuy lnc.
700 Orthopaedic Drive
Warsaw,  IN  46581 -0988
Applicant Contact Megan Bernier
Correspondent
DePuy lnc.
700 Orthopaedic Drive
Warsaw,  IN  46581 -0988
Correspondent Contact Megan Bernier
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT   MBF   PHX  
Date Received11/02/2020
Decision Date 04/02/2021
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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