CoreLink Midline Fixation System

Thoracolumbosacral Pedicle Screw System

CoreLink, LLC

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

Pre-market Notification Details

Device IDK210539
510k NumberK210539
Device Name:CoreLink Midline Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
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 CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-04-15

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