K241525
- 510(k) number
- K241525
- Device name
- ExcelsiusXR
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-07-08
- Date received
- 2024-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241525.pdf
Official FDA record: K241525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.