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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 K233228
Device Name Spine Navigation and Robotic-Assistance Device
Applicant
Ecential Robotics
2 Ave. De Vignate
Zone Mayencin Ii, Parc Equation - Batiment 1
Gieres,  FR 38610
Applicant Contact Amanie Yazidi
Correspondent
Ecential Robotics
2 Ave. De Vignate
Zone Mayencin Ii, Parc Equation - Batiment 1
Gieres,  FR 38610
Correspondent Contact Amanie Yazidi
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/28/2023
Decision Date 06/14/2024
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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