TRYPTIK2C-plate Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Tryptik2c-plate Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK153042
510k NumberK153042
Device Name:TRYPTIK2C-plate Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva,  CH 1215
ContactFranck Pennesi
CorrespondentFranck Pennesi
SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva,  CH 1215
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-19
Decision Date2016-03-28
Summary:summary

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