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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 K232628
Device Name VADER® Pedicle System
Applicant
Icotec AG
Industriestrasse 12
9450 Altstaetten (Sg),  CH
Applicant Contact Marina Hess
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
PML  
Date Received08/29/2023
Decision Date 02/26/2024
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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