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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K192236
Device Name Fitmore 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 Tobias Moller
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
JDI   KWL   KWZ   LWJ   LZO  
Date Received08/19/2019
Decision Date 11/05/2019
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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