K251316
- 510(k) number
- K251316
- Device name
- Mazor X System / Mazor X Stealth Edition
- Applicant
- Mazor Robotics , Ltd. IL
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-09-11
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251316.pdf
Official FDA record: K251316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.