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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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