K252087
- 510(k) number
- K252087
- Device name
- Navigation Module of the Cortium® System
- Applicant
- Ulrich Medical USA, Inc. TX · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-02-03
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252087.pdf
Official FDA record: K252087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.