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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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