F3D Cervical Stand-Alone Interbody Fusion System

Intervertebral Fusion Device With Integrated Fixation, Cervical

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for F3d Cervical Stand-alone Interbody Fusion System.

Pre-market Notification Details

Device IDK200087
510k NumberK200087
Device Name:F3D Cervical Stand-Alone Interbody Fusion System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant CoreLink, LLC 2072 Fenton Logistics Park Blvd. St. Louis,  MO  63206
ContactSteven Mounts
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-15
Decision Date2020-06-15

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