K250879
- 510(k) number
- K250879
- Device name
- Paradigm System
- Applicant
- Proprio, Inc. WA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-06-04
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K250879.pdf
Official FDA record: K250879
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.