IO Expandable Lumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

MiRus, LLC

The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Io Expandable Lumbar Interbody Fusion System.

Pre-market Notification Details

Device IDK210800
510k NumberK210800
Device Name:IO Expandable Lumbar Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MiRus, LLC 1755 West Oak Parkway, Suite 100 Marietta,  GA  30062
ContactJordan Bauman
CorrespondentJordan Bauman
MiRus, LLC 1755 West Oak Parkway, Suite 100 Marietta,  GA  30062
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-16
Decision Date2021-08-20

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.