RAMPART-L

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-l.

Pre-market Notification Details

Device IDK133371
510k NumberK133371
Device Name:RAMPART-L
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul,  MN  55128
ContactBryan Becker
CorrespondentBryan Becker
SPINEOLOGY, INC. 7800 3RD ST NORTH SUITE 600 St. Paul,  MN  55128
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-01
Decision Date2014-01-09
Summary:summary

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