SURGIVISIO Device

Orthopedic Stereotaxic Instrument

Ecential Robotics

The following data is part of a premarket notification filed by Ecential Robotics with the FDA for Surgivisio Device.

Pre-market Notification Details

Device IDK221028
510k NumberK221028
Device Name:SURGIVISIO Device
ClassificationOrthopedic Stereotaxic Instrument
Applicant Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres,  FR 38610
ContactSarah Lefevre-Billard
CorrespondentSarah Lefevre-Billard
Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres,  FR 38610
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-07-06

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