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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 K183630
Device Name SPINEART Navigation Instrument System
Applicant
Spineart SA
Chemin Du Pre- Fleuri 3
Plan-Les-Ouates,  CH 1228
Applicant Contact Franck Pennesi
Correspondent
Empirical Consulting, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/26/2018
Decision Date 06/10/2019
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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