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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K150730
Device Name Zimmer PSI Shoulder System
Applicant
Zimmer
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
Zimmer
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
KWS   PHX  
Date Received03/20/2015
Decision Date 06/16/2015
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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