Pantheon Spinal Pontus Interbody Fusion Device

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 Spinal Pontus Interbody Fusion Device.

Pre-market Notification Details

Device IDK181548
510k NumberK181548
Device Name:Pantheon Spinal Pontus Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin,  TX  78746
ContactBob Schultz
CorrespondentDave Lamb
Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin,  TX  78746
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-12
Decision Date2019-12-16

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