ExcelsiusXR
K-Number: K241525 · 2025-07-08
ApplicantGlobus Medical, Inc.
Decision Date2025-07-08
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ExcelsiusXR is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-07-08 under approval 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. It is manufactured by Globus Medical, Inc.. The 510(k) number is K241525.
When was ExcelsiusXR approved by the FDA?
ExcelsiusXR received FDA 510(k) clearance on 2025-07-08, under approval number K241525.
What company makes ExcelsiusXR?
ExcelsiusXR is manufactured by Globus Medical, Inc..
What is the FDA product code for ExcelsiusXR?
The FDA product code for ExcelsiusXR is SBF.
Other Devices by Globus Medical, Inc.
K161379ELSA Spacers
K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K160597INDEPENDENCE MIS Spacers
K161223TransContinental® M Spacers and InterContinental® Plate-Spacers
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
Related Devices (Code: SBF)
K190929xvision Spine system (XVS)Augmedics, Ltd.
K202152NextAR TKA PlatformMedacta International S.A.
K193559NextAR TKA PlatformMedacta Inernational SA
K210859NextAR Spine PlatformMedacta International S.A.
K211188xvision Spine system (XVS)Augmedics, Ltd.
K210153NextAR RSA PlatformMedacta International S.A.
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.