InFill Interbody Fusion Devices

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 Devices.

Pre-market Notification Details

Device IDK150206
510k NumberK150206
Device Name:InFill Interbody Fusion Devices
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant PINNACLE SPINE GROUP, LLC 1601 ELM STREET SUITE 300 Dallas,  TX  75201
ContactRebecca K. Pine
CorrespondentRebecca K. Pine
PINNACLE SPINE GROUP, LLC 1601 ELM STREET SUITE 300 Dallas,  TX  75201
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-29
Decision Date2015-04-03
Summary:summary

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