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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 K261113
Device Name Op.n™ Spine Navigation and Robotic Guidance
Applicant
Ecential Robotics
2 Ave. De Vignate
Zone Mayencin Ii, Parc Equation - Bâtiment 1
Gieres,  FR 38610
Applicant Contact Elodie Bouillet
Correspondent
Ecential Robotics
2 Ave. De Vignate
Zone Mayencin Ii, Parc Equation - Bâtiment 1
Gières,  FR 38610
Correspondent Contact Elodie Bouillet
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/03/2026
Decision Date 07/22/2026
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		 Yes
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