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FDA 510(k)

Excelsius3D

K-Number: K210912 · 2021-08-12

ApplicantGlobus Medical, Inc.
Decision Date2021-08-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Excelsius3D is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-12 under approval number K210912. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Excelsius3D?

Excelsius3D is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Globus Medical, Inc.. The 510(k) number is K210912.

When was Excelsius3D approved by the FDA?

Excelsius3D received FDA 510(k) clearance on 2021-08-12, under approval number K210912.

What company makes Excelsius3D?

Excelsius3D is manufactured by Globus Medical, Inc..

What is the FDA product code for Excelsius3D?

The FDA product code for Excelsius3D is OWB.

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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