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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K210539
Device Name CoreLink Midline Fixation System
Applicant
CoreLink, LLC
2072 Fenton Logistics Park Blvd.
St. Louis,  MO  63026
Applicant Contact Steven Mounts
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/24/2021
Decision Date 04/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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