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FDA 510(k)

AQrate Robotic Assistance System

K-Number: K182000 · 2019-01-29

ApplicantGlobus Medical, Inc.
Decision Date2019-01-29
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AQrate Robotic Assistance System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K182000. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQrate Robotic Assistance System?

AQrate Robotic Assistance System is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Globus Medical, Inc.. The 510(k) number is K182000.

When did AQrate Robotic Assistance System receive FDA 510(k) clearance?

AQrate Robotic Assistance System received FDA 510(k) clearance on 2019-01-29, under 510(k) number K182000.

Who is the listed applicant for AQrate Robotic Assistance System?

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

What is the FDA product code for AQrate Robotic Assistance System?

The FDA product code for AQrate Robotic Assistance System is HAW.

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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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