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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K193030
Device Name Avenir Muller Stem, Avenir Cemented Hip Stem
Applicant
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact Roberto Tommasini
Correspondent
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Correspondent Contact Melanie Mitrov
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   KWZ   LWJ   MEH  
Date Received10/30/2019
Decision Date 12/06/2019
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
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