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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
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Applicant Contact Annemie Rehor Kausch
Zimmer GmbH
Sulzerallee 8
Winterthur,  CH 8404
Correspondent Contact Danielle Jannuzzi Madureira
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
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