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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 K193211
Device Name Nano FortiFix® System
Applicant
Nanovis Spine, LLC
5865 E. State Rd. 14
Columbia City,  IN  46725
Applicant Contact Matthew Hedrick
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E Warden
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/21/2019
Decision Date 03/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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