Duo Lumbar Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Spineology Inc

The following data is part of a premarket notification filed by Spineology Inc with the FDA for Duo Lumbar Interbody Fusion Device.

Pre-market Notification Details

Device IDK182322
510k NumberK182322
Device Name:Duo Lumbar Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Spineology Inc 7800 Third Street N., Suite 600 St. Paul,  MN  55128
ContactKaren Roche
CorrespondentKaren Roche
Spineology Inc 7800 Third Street N., Suite 600 St. Paul,  MN  55128
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-27
Decision Date2018-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M7401001030 K182322 000
M7401001029 K182322 000
M7401001028 K182322 000
M7401001027 K182322 000

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