KASILOF Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Kahtnu Surgical, Inc

The following data is part of a premarket notification filed by Kahtnu Surgical, Inc with the FDA for Kasilof Cervical Plate System.

Pre-market Notification Details

Device IDK203154
510k NumberK203154
Device Name:KASILOF Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Kahtnu Surgical, Inc 170 E. Corral Ave. Suite 1 Soldotna,  AK  99669
ContactCraig Wilcox
CorrespondentAnn Dunahoo
MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-22
Decision Date2020-11-05

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