Mazor X System / Mazor X Stealth Edition
K-Number: K251316 · 2025-09-11
ApplicantMazor Robotics , Ltd.
Decision Date2025-09-11
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 2025-09-11 under approval number K251316. 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 2025-09-11. It is manufactured by Mazor Robotics , Ltd.. The 510(k) number is K251316.
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 2025-09-11, under approval number K251316.
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.