Mazor X System (Mazor X Stealth Edition)
K-Number: K182077 · 2018-11-02
ApplicantMazor Robotics , Ltd.
Decision Date2018-11-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Mazor X System (Mazor X Stealth Edition) is a medical device manufactured by Mazor Robotics , Ltd.. It received FDA 510(k) clearance on 2018-11-02 under approval number K182077. 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 System (Mazor X Stealth Edition)?
Mazor X System (Mazor X Stealth Edition) is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Mazor Robotics , Ltd.. The 510(k) number is K182077.
When was Mazor X System (Mazor X Stealth Edition) approved by the FDA?
Mazor X System (Mazor X Stealth Edition) received FDA 510(k) clearance on 2018-11-02, under approval number K182077.
What company makes Mazor X System (Mazor X Stealth Edition)?
Mazor X System (Mazor X Stealth Edition) is manufactured by Mazor Robotics , Ltd..
What is the FDA product code for Mazor X System (Mazor X Stealth Edition)?
The FDA product code for Mazor X System (Mazor X Stealth Edition) 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.