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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 K242933
Device Name SPINEART Navigation Instrument System
Applicant
Spineart SA
3 Chemin Du Pré-Fleuri
Plan Les Ouates,  CH 1228
Applicant Contact Estelle Lefeuvre
Correspondent
Spineart SA
3 Chemin Du Pré-Fleuri
Plan Les Ouates,  CH 1228
Correspondent Contact Estelle Lefeuvre
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/25/2024
Decision Date 06/18/2025
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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