K252950
- 510(k) number
- K252950
- Device name
- Paradigm System
- Applicant
- Proprio, Inc. WA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-12-15
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252950.pdf
Official FDA record: K252950
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.