COGENT MED-LIF

Intervertebral Fusion Device With Bone Graft, Lumbar

COGENT SPINE LLC

The following data is part of a premarket notification filed by Cogent Spine Llc with the FDA for Cogent Med-lif.

Pre-market Notification Details

Device IDK132738
510k NumberK132738
Device Name:COGENT MED-LIF
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant COGENT SPINE LLC 101 N. ACACIA AVE SUITE 106 Solana Beach,  CA  92075
ContactJude Paganelli
CorrespondentJude Paganelli
COGENT SPINE LLC 101 N. ACACIA AVE SUITE 106 Solana Beach,  CA  92075
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-03
Decision Date2014-04-15
Summary:summary

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