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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K192217
Device Name NCB Plating System Distal Femur and Proximal Tibia
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Annemie Rehor Kausch
Correspondent
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Tiana Steinhoff
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/15/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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