FOUNDATION CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

CORELINK LLC

The following data is part of a premarket notification filed by Corelink Llc with the FDA for Foundation Cage.

Pre-market Notification Details

Device IDK073440
510k NumberK073440
Device Name:FOUNDATION CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-07
Decision Date2008-04-24
Summary:summary

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