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FDA 510(k)

ExcelsiusGPS Cranial 1.0 Module

K-Number: K200047 · 2020-07-10

ApplicantGlobus Medical, Inc.
Decision Date2020-07-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusGPS Cranial 1.0 Module is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K200047. 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 Cranial 1.0 Module?

ExcelsiusGPS Cranial 1.0 Module is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Globus Medical, Inc.. The 510(k) number is K200047.

When was ExcelsiusGPS Cranial 1.0 Module approved by the FDA?

ExcelsiusGPS Cranial 1.0 Module received FDA 510(k) clearance on 2020-07-10, under approval number K200047.

What company makes ExcelsiusGPS Cranial 1.0 Module?

ExcelsiusGPS Cranial 1.0 Module is manufactured by Globus Medical, Inc..

What is the FDA product code for ExcelsiusGPS Cranial 1.0 Module?

The FDA product code for ExcelsiusGPS Cranial 1.0 Module is OLO.

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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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