Duo Expandable Interbody Fusion System

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 Expandable Interbody Fusion System.

Pre-market Notification Details

Device IDK210155
510k NumberK210155
Device Name:Duo Expandable Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul,  MN  55128
ContactAndrew Adams
CorrespondentAndrew Adams
Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul,  MN  55128
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-02-19

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