K261060
- 510(k) number
- K261060
- Device name
- Navigated LLIF Impactable Tracker
- Applicant
- Tyber Medical, LLC PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-05-29
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261060.pdf
Official FDA record: K261060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.