AUDERE Lumbar Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Met One Technologies

The following data is part of a premarket notification filed by Met One Technologies with the FDA for Audere Lumbar Spacer System.

Pre-market Notification Details

Device IDK193457
510k NumberK193457
Device Name:AUDERE Lumbar Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Met One Technologies 513 W. San Antonio Ave, Suite C El Paso,  TX  79901
ContactKyle Atwood
CorrespondentEvan Carbonell
Met One Technologies 513 W. San Antonio Ave, Suite C El Paso,  TX  79901
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-05-12

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