ExcelsiusGPS Instruments
K-Number: K250599 · 2025-11-05
ApplicantGlobus Medical, Inc.
Decision Date2025-11-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ExcelsiusGPS Instruments is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-11-05 under approval number K250599. 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 2025-11-05. It is manufactured by Globus Medical, Inc.. The 510(k) number is K250599.
When was ExcelsiusGPS Instruments approved by the FDA?
ExcelsiusGPS Instruments received FDA 510(k) clearance on 2025-11-05, under approval number K250599.
What company makes ExcelsiusGPS Instruments?
ExcelsiusGPS Instruments is manufactured by Globus Medical, Inc..
What is the FDA product code for ExcelsiusGPS Instruments?
The FDA product code for ExcelsiusGPS Instruments is OLO.
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K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
K151665SUSTAIN Additional Implants
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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.