K243671
- 510(k) number
- K243671
- Device name
- ExcelsiusGPS® Instruments
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-12-20
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243671.pdf
Official FDA record: K243671
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.