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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 K190545
Device Name VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
icotec ag
Industriestrasse 12
9450 Altstaetten,  CH
Applicant Contact Marina Hess
Musculosketal Clinical Regulatory Affairs
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3070
Classification Product Code
Date Received03/04/2019
Decision Date 06/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT02087267
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls