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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 K221028
Device Name SURGIVISIO Device
Applicant
Ecential Robotics
Zone Mayencin Ii, Parc Equation - Bâtiment 1,
2 Ave. De Vignate
Gieres,  FR 38610
Applicant Contact Sarah Lefevre-Billard
Correspondent
Ecential Robotics
Zone Mayencin Ii, Parc Equation - Bâtiment 1,
2 Ave. De Vignate
Gieres,  FR 38610
Correspondent Contact Sarah Lefevre-Billard
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/07/2022
Decision Date 07/06/2022
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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