Cervical Plate

Appliance, Fixation, Spinal Intervertebral Body

EiserTech, LLC

The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Cervical Plate.

Pre-market Notification Details

Device IDK190565
510k NumberK190565
Device Name:Cervical Plate
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant EiserTech, LLC 9988 Hibert Street Suite 302 San Diego,  CA  92131
ContactLukas Eisermann
CorrespondentDawn Norman
MRC-X, LLC 6075 Poplar Ave Memphis,  TN  38119
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-05
Decision Date2019-05-31

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