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FDA 510(k)

ExcelsiusHub

K-Number: K211616 · 2021-08-25

ApplicantGlobus Medical, Inc.
Decision Date2021-08-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusHub is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2021-08-25 under approval number K211616. 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 ExcelsiusHub?

ExcelsiusHub is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Globus Medical, Inc.. The 510(k) number is K211616.

When was ExcelsiusHub approved by the FDA?

ExcelsiusHub received FDA 510(k) clearance on 2021-08-25, under approval number K211616.

What company makes ExcelsiusHub?

ExcelsiusHub is manufactured by Globus Medical, Inc..

What is the FDA product code for ExcelsiusHub?

The FDA product code for ExcelsiusHub is OLO.

Other Devices by Globus Medical, Inc.

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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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