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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, Hemi-, Humeral, Metallic Uncemented
510(k) Number K161620
Device Name Anatomical Shoulder Domelock Dome centric
Applicant
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact ROBERTO TOMMASINI
Correspondent
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Correspondent Contact ANNEMIE REHOR KAUSCH
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Codes
KWS   KWT   PHX  
Date Received06/13/2016
Decision Date 11/01/2016
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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