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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
Sulzerallee 8
winterthur,  CH 8404
Applicant Contact annemie rehor kausch
Correspondent
Zimmer GmbH
Sulzerallee 8
winterthur,  CH 8404
Correspondent Contact danielle jannuzzi madureira
Regulation Number888.3020
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
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