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FDA 510(k)

THE ARTAS SYSTEM

K-Number: K123548 · 2013-02-25

ApplicantRestoration Robotics, Inc.
Decision Date2013-02-25
Product CodeONA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE ARTAS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Restoration Robotics, Inc.. It received FDA 510(k) clearance on 2013-02-25 under 510(k) number K123548. The device is classified under product code ONA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ARTAS SYSTEM?

THE ARTAS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-25. The listed applicant is Restoration Robotics, Inc.. The 510(k) number is K123548.

When did THE ARTAS SYSTEM receive FDA 510(k) clearance?

THE ARTAS SYSTEM received FDA 510(k) clearance on 2013-02-25, under 510(k) number K123548.

Who is the listed applicant for THE ARTAS SYSTEM?

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

What is the FDA product code for THE ARTAS SYSTEM?

The FDA product code for THE ARTAS SYSTEM is ONA.

Related Clinical Trials

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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Other records listing Restoration Robotics, Inc. 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.

K173358ARTAS SystemK123154ARTAS SYSTEM FROM RESTORATION ROBOTICSK103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICS

Related Devices (Code: ONA)

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.

K173358ARTAS SystemRestoration Robotics, Inc.K123154ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.K103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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