Pantheon IBFD

Intervertebral Fusion Device With Bone Graft, Lumbar

Pantheon Spinal

The following data is part of a premarket notification filed by Pantheon Spinal with the FDA for Pantheon Ibfd.

Pre-market Notification Details

Device IDK203003
510k NumberK203003
Device Name:Pantheon IBFD
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown,  TX  78626
ContactDave Lamb
CorrespondentDave Lamb
Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown,  TX  78626
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2021-07-07

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