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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 K193465
Device Name CorticaLINK Spinal Fusion Platform
Applicant
Spine Smith Holdings, LLC
4719 South Congress Ave.
Austin,  TX  78745
Applicant Contact Nickolas G. Kriska
Correspondent
Spine Smith Holdings, LLC
4719 South Congress Ave.
Austin,  TX  78745
Correspondent Contact Nickolas G. Kriska
Regulation Number888.3070
Classification Product Code
NKB  
Date Received12/16/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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