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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 K254158
Device Name SPINEART Navigation Instrument System
Applicant
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Applicant Contact Estelle Lefeuvre
Correspondent
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Correspondent Contact Estelle Lefeuvre
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/22/2025
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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