ExcelsiusGPS™ Instruments

by Globus Medical, Inc.

510(k) K250599

ExcelsiusGPS™ Instruments is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K250599 on 5 Nov 2025, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

510(k) K250599↗

FDA record

Trust

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK250599	Date5 Nov 2025Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K250599

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K250599
FDA product code: OLO

Device class: Class II
Regulation: 21 CFR Part 882.4560
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

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