Zimmer Natural Nail System Cephalomedullary Nails

Rod, Fixation, Intramedullary And Accessories

Zimmer GmbH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Natural Nail System Cephalomedullary Nails.

Pre-market Notification Details

Device IDK192312
510k NumberK192312
Device Name:Zimmer Natural Nail System Cephalomedullary Nails
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Zimmer GmbH Sulzerallee 8 Winterthur,  CH 8404
ContactAnnemie Rehor Kausch
CorrespondentDanielle Jannuzzi Madureira
Zimmer GmbH Sulzerallee 8 Winterthur,  CH 8404
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-26
Decision Date2019-10-11
Summary:summary

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