Device details
FDA 510(k) registration fields
- K number
- K251316
- Device name
- Mazor X System / Mazor X Stealth Edition
- Company
- Mazor Robotics , Ltd.
- Country / Region
- Israel(IL)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-29
- Decision date
- 2025-09-11
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
