Identity
- Trade Name
- MAZOR X Stealth Edition EUDAMEDSchanz Screw 4X150mm FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- Mazor X Accessories EUDAMED
- Model / Reference
- KIT2865 EUDAMEDMAS2865-03 FDA UDI
Identifiers
- Catalog Number
- KIT2865-03 FDA UDI
- Primary DI / UDI-DI
- 07290115752380 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00026448E EUDAMED
- 510(k) Number
- K230064 FDA UDI
- FDA Product Code
- OLO FDA UDILLZ FDA UDI
- EMDN Code
- Z12130401 STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS EUDAMED
- GMDN Term
- Stereotactic surgery system probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI892.2050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MAZOR X Stealth Edition by Mazor Robotics Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763000B00026448E | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Mazor Robotics Ltd.
- EUDAMED SRN
- IL-MF-000020000
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (2)
- EUDAMED 3c897724-0743-4b69-aec6-f81cfb47f5b3 61 fields · synced Jul 17, 2026
- FDA UDI 53be08c4-e4f5-4800-ae24-3374bc97e670 34 fields · synced May 24, 2026