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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mazor Robotics , Ltd.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) 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. The listed applicant is Mazor Robotics , Ltd.. The 510(k) number is K251316.

When did Mazor X System / Mazor X Stealth Edition receive FDA 510(k) clearance?

Mazor X System / Mazor X Stealth Edition received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251316.

Who is the listed applicant for Mazor X System / Mazor X Stealth Edition?

The FDA 510(k) record lists Mazor Robotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Mazor Robotics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230064Mazor X System (Mazor X Stealth Edition)K203005Mazor XK200935Mazor XK182077Mazor X System (Mazor X Stealth Edition)K180307Mazor XK172522Mazor X

View all 8 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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