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FDA 510(k)

ExcelsiusGPS® Instruments

K-Number: K243671 · 2024-12-20

ApplicantGlobus Medical, Inc.
Decision Date2024-12-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusGPS® Instruments 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 2024-12-20 under 510(k) number K243671. 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® Instruments?

ExcelsiusGPS® Instruments is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K243671.

When did ExcelsiusGPS® Instruments receive FDA 510(k) clearance?

ExcelsiusGPS® Instruments received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243671.

Who is the listed applicant for ExcelsiusGPS® Instruments?

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 ExcelsiusGPS® Instruments?

The FDA product code for ExcelsiusGPS® Instruments 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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