← Back to catalogue
MAZOR X Stealth Edition
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref MAS2255Ref MAS2345Ref KIT2480Ref KIT0854Ref MAS2176Ref KIT0142Ref MAS2261
Identity
- Trade Name
- MAZOR X Stealth Edition EUDAMEDStylus Marker FDA UDIMazor X Guidewire Instruments Set FDA UDIBlunt FDA UDISA Reduction Tube, 10 pack FDA UDITarget Extender Screw FDA UDIShort Drill 3x30mm FDA UDIRadiolucent MIS Clamp FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- Mazor X Accessories EUDAMED
- Model / Reference
- MAS2255 EUDAMEDMAS2345 EUDAMEDKIT2480 EUDAMEDKIT0854 EUDAMEDMAS2176 EUDAMEDKIT0142 EUDAMEDMAS2261 EUDAMEDMAS2176-07S FDA UDIKIT0854-04 FDA UDIMAS2255-08S FDA UDIKIT0142-08 FDA UDIMAS2345-06S FDA UDIMAS2261-07S FDA UDIMAS2480-04 FDA UDI
Identifiers
- Catalog Number
- KIT2480-03 FDA UDI
- Primary DI / UDI-DI
- 07290115752731 EUDAMEDFDA UDI07290115752120 EUDAMEDFDA UDI07290115751437 EUDAMEDFDA UDI07290115752779 EUDAMEDFDA UDI07290115752618 EUDAMEDFDA UDI07290115752656 EUDAMEDFDA UDI07290115752304 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 UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDIFDA 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mazor Robotics Ltd.
- EUDAMED SRN
- IL-MF-000020000
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (14)
- EUDAMED e84be69d-275c-4be5-b99d-65c7c1be347a 61 fields · synced Aug 3, 2026
- FDA UDI 9f08b6fe-1e8e-4a06-8f64-d1bd12697f7c 33 fields · synced May 26, 2026
- FDA UDI 3d43f32d-25ea-438e-a3d4-214993b3fb2d 33 fields · synced May 29, 2026
- FDA UDI 86018864-5941-4b50-8f41-873cbe621b5f 33 fields · synced May 30, 2026
- FDA UDI e490985d-12d0-4f92-89dd-6dc2e2a18898 33 fields · synced May 30, 2026
- FDA UDI 29cf007c-bc11-4d45-85d3-a9d8f4f810c7 33 fields · synced May 30, 2026
- FDA UDI c3c4e2d2-c976-4dc6-a7a6-9c1ad7ca860b 33 fields · synced May 30, 2026
- FDA UDI fd990a85-4bac-45a7-b37f-f5a316863546 34 fields · synced May 30, 2026
- EUDAMED a62b4b95-cf67-490b-8418-3c7c838bc3e8 61 fields · synced Jul 10, 2026
- EUDAMED 601b83ab-b908-41c7-b7e9-1af73bca6a62 61 fields · synced Jul 12, 2026
- EUDAMED bbeedca9-d537-443e-b2e3-3c7456a61b8e 61 fields · synced Jul 17, 2026
- EUDAMED ee296015-4eaa-4bbd-bf60-5ec1d95b27ec 61 fields · synced Jul 22, 2026
- EUDAMED b36c8d6f-c6cb-4179-831f-a3b6e7c86710 61 fields · synced Jul 30, 2026
- EUDAMED 29709233-2ae4-472f-9d5f-ee0f3dcf8c96 61 fields · synced Aug 3, 2026