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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K192312
Device Name Zimmer Natural Nail System Cephalomedullary Nails
Applicant
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact Annemie Rehor Kausch
Correspondent
Zimmer GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Correspondent Contact Danielle Jannuzzi Madureira
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/26/2019
Decision Date 10/11/2019
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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