Identity
- Trade Name
- MAZOR X Stealth Edition EUDAMED5.5/6.0 Arm Guide Kit FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- Mazor X Navigation Accessories EUDAMED
- Model / Reference
- KIT0897 EUDAMEDKIT0897-06 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115751345 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00026458G 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 I 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 I — 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 | 0763000B00026458G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 70aafae8-92ed-4586-9305-ad6495f6498f 61 fields · synced Jul 10, 2026
- FDA UDI f6f81a37-793a-43e5-bade-480266eba6b6 33 fields · synced May 30, 2026