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FDA 510(k)

ExcelsiusGPS

K-Number: K190653 · 2019-04-09

ApplicantGlobus Medical, Inc.
Decision Date2019-04-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusGPS is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-04-09 under approval number K190653. 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 ExcelsiusGPS?

ExcelsiusGPS is a medical device that received FDA 510(k) clearance on 2019-04-09. It is manufactured by Globus Medical, Inc.. The 510(k) number is K190653.

When was ExcelsiusGPS approved by the FDA?

ExcelsiusGPS received FDA 510(k) clearance on 2019-04-09, under approval number K190653.

What company makes ExcelsiusGPS?

ExcelsiusGPS is manufactured by Globus Medical, Inc..

What is the FDA product code for ExcelsiusGPS?

The FDA product code for ExcelsiusGPS is OLO.

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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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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