Mazor X
K-Number: K200935 · 2020-05-08
ApplicantMazor Robotics , Ltd.
Decision Date2020-05-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Mazor X is a medical device manufactured by Mazor Robotics , Ltd.. It received FDA 510(k) clearance on 2020-05-08 under approval number K200935. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mazor X?
Mazor X is a medical device that received FDA 510(k) clearance on 2020-05-08. It is manufactured by Mazor Robotics , Ltd.. The 510(k) number is K200935.
When was Mazor X approved by the FDA?
Mazor X received FDA 510(k) clearance on 2020-05-08, under approval number K200935.
What company makes Mazor X?
Mazor X is manufactured by Mazor Robotics , Ltd..
What is the FDA product code for Mazor X?
The FDA product code for Mazor X is OLO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.