Rampart One Lumbar Interbody Fusion Device

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SPINEOLOGY INC.

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

Pre-market Notification Details

Device IDK163670
510k NumberK163670
Device Name:Rampart One Lumbar Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Integrated Fixation, 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 CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-27
Decision Date2017-05-08
Summary:summary

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