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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810116512690 K210800 000
00810025487713 K210800 000
00810025487720 K210800 000
00810025487737 K210800 000
00810025487744 K210800 000
00810025487751 K210800 000
00810116512621 K210800 000
00810116512638 K210800 000
00810116512645 K210800 000
00810116512652 K210800 000
00810116512669 K210800 000
00810116512676 K210800 000
00810116512683 K210800 000
00810025487706 K210800 000

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