Foundation 3D Interbody

Intervertebral Fusion Device With Bone Graft, Cervical

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Foundation 3d Interbody.

Pre-market Notification Details

Device IDK162496
510k NumberK162496
Device Name:Foundation 3D Interbody
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant CoreLink, LLC 7911 Forsyth Blvd, Suite # 200 St. Louis,  MO  63105
ContactStephan Jones
CorrespondentKenneth C. Maxwell Ii
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-07
Decision Date2017-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M7253CZ18 K162496 000
M7253CZ16 K162496 000
M7253CZ14 K162496 000
M7253CF18 K162496 000
M7253CF16 K162496 000
M7253CF14 K162496 000

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