InFill Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Pinnacle Spine Group, LLC

The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill Interbody Fusion Device.

Pre-market Notification Details

Device IDK152259
510k NumberK152259
Device Name:InFill Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Pinnacle Spine Group, LLC 1601 Elm Street Suite 1930 Dallas,  TX  75201
ContactRebecca K Pine
CorrespondentRebecca K Pine
Pinnacle Spine Group, LLC 1601 Elm Street Suite 1930 Dallas,  TX  75201
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-11
Decision Date2015-11-19
Summary:summary

NIH GUDID Devices

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