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FDA 510(k)

ARTAS System

K-Number: K173358 · 2018-03-16

ApplicantRestoration Robotics, Inc.
Decision Date2018-03-16
Product CodeONA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARTAS System is a medical device manufactured by Restoration Robotics, Inc.. It received FDA 510(k) clearance on 2018-03-16 under approval number K173358. 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 ARTAS System?

ARTAS System is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Restoration Robotics, Inc.. The 510(k) number is K173358.

When was ARTAS System approved by the FDA?

ARTAS System received FDA 510(k) clearance on 2018-03-16, under approval number K173358.

What company makes ARTAS System?

ARTAS System is manufactured by Restoration Robotics, Inc..

What is the FDA product code for ARTAS System?

The FDA product code for ARTAS System is ONA.

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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