Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

Intervertebral Fusion Device With Bone Graft, Lumbar

Intelivation LLC

The following data is part of a premarket notification filed by Intelivation Llc with the FDA for Advantage Lumbar System - Alif, Plif, Dlif, Tlif.

Pre-market Notification Details

Device IDK212389
510k NumberK212389
Device Name:Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Intelivation LLC 70 Gruber Lane Saint Simons Island,  GA  31522
ContactAmit Sinha
CorrespondentBarry Sands
RQMIS Inc. 110 Haverhill Road Suite 524 Amesbury,  MA  01913
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-10-29

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