K242464
- 510(k) number
- K242464
- Device name
- Stealth Spine Clamps; ModuLeX Shank Mounts
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-06-05
- Date received
- 2024-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K242464.pdf
Official FDA record: K242464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.