Mazor X

Orthopedic Stereotaxic Instrument

Mazor Robotics Ltd.

The following data is part of a premarket notification filed by Mazor Robotics Ltd. with the FDA for Mazor X.

Pre-market Notification Details

Device IDK200935
510k NumberK200935
Device Name:Mazor X
ClassificationOrthopedic Stereotaxic Instrument
Applicant Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea,  IL 3079567
ContactShiran Conforti
CorrespondentShiran Conforti
Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea,  IL 3079567
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-05-08

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