K250599
- 510(k) number
- K250599
- Device name
- ExcelsiusGPS Instruments
- Applicant
- Globus Medical, Inc. CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-11-05
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K250599.pdf
Official FDA record: K250599
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.