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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-12 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K210912.

When did Excelsius3D receive FDA 510(k) clearance?

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

Who is the listed applicant for Excelsius3D?

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 Excelsius3D?

The FDA product code for Excelsius3D is OWB.

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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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