Stryker Facial ID Plating System

Plate, Bone

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Facial Id Plating System.

Pre-market Notification Details

Device IDK193143
510k NumberK193143
Device Name:Stryker Facial ID Plating System
ClassificationPlate, Bone
Applicant Stryker 750 Trade Centre Way- Suite 200 Portage,  MI  49002
ContactZainab Amini
CorrespondentZainab Amini
Stryker 750 Trade Centre Way- Suite 200 Portage,  MI  49002
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-03-26

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