F3D Corpectomy System

Spinal Vertebral Body Replacement Device

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for F3d Corpectomy System.

Pre-market Notification Details

Device IDK202637
510k NumberK202637
Device Name:F3D Corpectomy System
ClassificationSpinal Vertebral Body Replacement Device
Applicant CoreLink, LLC 2072 Fenton Logistics Park Blvd. St.louis,  MO  63026
ContactSteven Mounts
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2020-12-23

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