K240721
- 510(k) number
- K240721
- Device name
- ExcelsiusFlex
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-06-14
- Date received
- 2024-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240721.pdf
Official FDA record: K240721
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.