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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 K200112
Device Name Zimmer Hip Joint Replacement
Applicant
Zimmer GmbH
Sulzer Allee 6
Winterthur,  CH 8404
Applicant Contact Thomas Lincoln
Correspondent
Zimmer GmbH
Sulzer Allee 6
Winterthur,  CH 8404
Correspondent Contact Anne-Kathrin Born
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   MEH  
Date Received01/17/2020
Decision Date 04/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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