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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 K223806
Device Name VERTICALE® Triangular Fixation System
Applicant
Silony Medical GmbH
Leinfelder Strabe 60
Leinfelden-Echterdingen,  DE 70771
Applicant Contact Ralf Klabunde
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3070
Classification Product Code
NKB  
Date Received12/19/2022
Decision Date 07/06/2023
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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