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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 K192021
Device Name NCB Polyaxial Locking Plate System
Applicant
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Annemie Rehor Kausch
Correspondent
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Danielle Jannuzzi Madureira
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/29/2019
Decision Date 08/22/2019
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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