K252880
- 510(k) number
- K252880
- Device name
- Pytheas Your Guided Trajectory
- Applicant
- Pytheas Navigation Sas FR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-05-11
- Date received
- 2025-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252880.pdf
Official FDA record: K252880
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.