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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 a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-01-29 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K182000.

When was AQrate Robotic Assistance System approved by the FDA?

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

What company makes AQrate Robotic Assistance System?

AQrate Robotic Assistance System is manufactured by Globus Medical, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41725549 Ethical and legal challenges of integrating artificial intelligence into paediatric surgery. Annals of the Royal College of Surgeons of England (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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Related Devices (Code: 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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