MAZOR X Stealth Edition
by Mazor Robotics Ltd. 2 variants
Ref KIT0575
MAZOR X Stealth Edition (KIT0575) is a Class IIb device made by Mazor Robotics Ltd, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0763000B00035098E), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0763000B00035098E 07290115753448 | Date22 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 0763000B00035098E
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Mazor X Spine Disposable Tray
- Model / reference
- KIT0575
- Primary DI / UDI-DI
- 07290115753448
- Basic UDI-DI
- 0763000B00035098E
- EMDN code
- Z12130401 Stereotactic orthopaedic surgery systems
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IL-MF-000020000
- Authorised representative
- Medtronic B.V. NL-AR-000006050
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