SPINEOLOGY PEEK BULLET 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 Spineology Peek Bullet Lumbar Interbody Fusion Device.

Pre-market Notification Details

Device IDK113030
510k NumberK113030
Device Name:SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul,  MN  55128
ContactBryan Becker
CorrespondentBryan Becker
SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul,  MN  55128
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-12
Decision Date2012-01-26
Summary:summary

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