Rampart A 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 Rampart A Lumbar Interbody Fusion Device.

Pre-market Notification Details

Device IDK153082
510k NumberK153082
Device Name:Rampart A Lumbar Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINEOLOGY, INC. 7800 3RD STREET N, SUITE 600 St. Paul,  MN  55128
ContactJacqueline A Hauge
CorrespondentJacqueline A Hauge
SPINEOLOGY, INC. 7800 3RD STREET N, SUITE 600 St. Paul,  MN  55128
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-23
Decision Date2016-02-04
Summary:summary

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