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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 K173484
Device Name CorticaLINK Spinal Fusion Platform
Applicant
Linkspine, Inc.
5950 Symphony Woods Rd., Suite 620
Columbia,  MD  21044
Applicant Contact Nickolas Kriska
Correspondent
Linkspine, Inc.
5950 Symphony Woods Rd., Suite 620
Columbia,  MD  21044
Correspondent Contact Nickolas G. Kriska
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/13/2017
Decision Date 12/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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