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FDA 510(k)

ExcelsiusXR™

K-Number: K241525 · 2025-07-08

ApplicantGlobus Medical, Inc.
Decision Date2025-07-08
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ExcelsiusXR™ 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 2025-07-08 under 510(k) number K241525. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExcelsiusXR™?

ExcelsiusXR™ is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Globus Medical, Inc.. The 510(k) number is K241525.

When did ExcelsiusXR™ receive FDA 510(k) clearance?

ExcelsiusXR™ received FDA 510(k) clearance on 2025-07-08, under 510(k) number K241525.

Who is the listed applicant for ExcelsiusXR™?

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 ExcelsiusXR™?

The FDA product code for ExcelsiusXR™ is SBF.

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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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