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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 K191726
Device Name mont blanc & mont blanc MIS Spinal Systems
Applicant
Spineway SA
7 Allee Moulin Berger
Ecully,  FR 69130
Applicant Contact Heloise Macaire
Correspondent
Novus Management Group, LLC
6686 Dimmick Rd.
West Chester,  OH  45069
Correspondent Contact Tamala J. Wampler
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received06/27/2019
Decision Date 09/12/2019
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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