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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 K191781
Device Name Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Roberto Tommasini
Correspondent
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Anne-Kathrin Born
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWZ   LPH  
Date Received07/02/2019
Decision Date 08/06/2019
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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