QUINTEX CERVICAL PLATING SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Quintex Cervical Plating System.

Pre-market Notification Details

Device IDK121801
510k NumberK121801
Device Name:QUINTEX CERVICAL PLATING SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa Boyle
CorrespondentLisa Boyle
AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-19
Decision Date2012-09-11
Summary:summary

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