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FDA 510(k)

ExcelsiusGPS Spine 1.1 Interbody Module

K-Number: K191100 · 2019-07-24

ApplicantGlobus Medical, Inc.
Decision Date2019-07-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusGPS Spine 1.1 Interbody Module is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-07-24 under approval number K191100. 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 Spine 1.1 Interbody Module?

ExcelsiusGPS Spine 1.1 Interbody Module is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Globus Medical, Inc.. The 510(k) number is K191100.

When was ExcelsiusGPS Spine 1.1 Interbody Module approved by the FDA?

ExcelsiusGPS Spine 1.1 Interbody Module received FDA 510(k) clearance on 2019-07-24, under approval number K191100.

What company makes ExcelsiusGPS Spine 1.1 Interbody Module?

ExcelsiusGPS Spine 1.1 Interbody Module is manufactured by Globus Medical, Inc..

What is the FDA product code for ExcelsiusGPS Spine 1.1 Interbody Module?

The FDA product code for ExcelsiusGPS Spine 1.1 Interbody 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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