K252742
- 510(k) number
- K252742
- Device name
- Navigated Instruments
- Applicant
- Tyber Medical, LLC PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-10-28
- Date received
- 2025-08-28
- 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: K252742.pdf
Official FDA record: K252742
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.