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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 K254148
Device Name VERTICALE GPS Instruments
Applicant
Silony Medical GmbH
Leinfelder Strasse 60
Leinfelden-Echterdingen,  DE 70771
Applicant Contact Raphael Venzin
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/22/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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