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FDA 510(k)

Mazor X

K-Number: K203005 · 2020-10-27

ApplicantMazor Robotics , Ltd.
Decision Date2020-10-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mazor X 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 2020-10-27 under 510(k) number K203005. 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 2020-10-27. The listed applicant is Mazor Robotics , Ltd.. The 510(k) number is K203005.

When did Mazor X receive FDA 510(k) clearance?

Mazor X received FDA 510(k) clearance on 2020-10-27, under 510(k) number K203005.

Who is the listed applicant for Mazor X?

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?

The FDA product code for Mazor X 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.

K251316Mazor X System / Mazor X Stealth EditionK230064Mazor X System (Mazor X Stealth Edition)K200935Mazor XK182077Mazor X System (Mazor X Stealth Edition)K180307Mazor XK172522Mazor X

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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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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