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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K192013
Device Name VERTICALE® Cervical System
Applicant
Silony Medical GmbH
Leinfelder Strabe 60
Leinfelden-Echterdingen,  DE 70771
Applicant Contact Melanie Lubjuhn
Correspondent
Silony Medical GmbH
Leinfelder Strabe 60
Leinfelden-Echterdingen,  DE 70771
Correspondent Contact Melanie Lubjuhn
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received07/29/2019
Decision Date 04/07/2020
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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