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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 K210472
Device Name SPINEART Navigation Instrument System
Applicant
Spineart
3 Chemin Du Pré Fleuri
Plan Les Ouates,  CH 1228
Applicant Contact Franck Pennesi
Correspondent
Spineart
3 Chemin Du Pré Fleuri
Plan Les Ouates,  CH 1228
Correspondent Contact Franck Pennesi
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/17/2021
Decision Date 03/19/2021
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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