Pyrenees Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

K2M, Inc

The following data is part of a premarket notification filed by K2m, Inc with the FDA for Pyrenees Cervical Plate System.

Pre-market Notification Details

Device IDK142212
510k NumberK142212
Device Name:Pyrenees Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant K2M, Inc 751 Miller Drive Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, Inc 751 Miller Drive Leesburg,  VA  20175
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-12
Decision Date2015-05-01
Summary:summary

NIH GUDID Devices

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