K233299
- 510(k) number
- K233299
- Device name
- ExactechGPS® System
- Applicant
- Blue Ortho FR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-01-26
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K233299.pdf
Official FDA record: K233299
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.