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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K223649
Device Name VERTICALE® Navigation Instruments
Applicant
Silony Medical GmbH
Leinfelder Strabe 60
Leinfelden-Echterdingen,  DE D-70771
Applicant Contact Ralf Klabunde
Correspondent
Silony Medical GmbH
Leinfelder Strabe 60
Leinfelden-Echterdingen,  DE D-70771
Correspondent Contact Lisa Schwarz
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/06/2022
Decision Date 12/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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