Identity
- Trade Name
- Mazor X Spine Disposable Kit FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Model / Reference
- KIT0574-11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115753141 FDA UDI
- 510(k) Number
- K230064 FDA UDI
- FDA Product Code
- OLO FDA UDILLZ FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, single-use
Mazor X Spine Disposable Kit by Mazor Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Cleared under the same submission
K230064 also covers:
- Long Drill 4x80mm, 10 pack — MAZOR ROBOTICS LTD
- Mazor X Navigation Camera — MAZOR ROBOTICS LTD
- Mazor X Navigation Camera — MAZOR ROBOTICS LTD
- Mazor X Scan & Plan Disposable Kit — MAZOR ROBOTICS LTD
- Mazor X Scan & Plan Disposable Kit — MAZOR ROBOTICS LTD
- Mazor X Spine Disposable Kit — MAZOR ROBOTICS LTD
- Mazor X Spine Disposable Kit — MAZOR ROBOTICS LTD
- Mazor X System — MAZOR ROBOTICS LTD
- Short Clamp — MAZOR ROBOTICS LTD
- Standard Bridge — MAZOR ROBOTICS LTD
- Target Extender — MAZOR ROBOTICS LTD
- Universal Screwdriver — MAZOR ROBOTICS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mazor Robotics Ltd
Sources (1)
- FDA UDI 9241dd77-4776-4ef4-bc91-db373edd8b13 33 fields · synced May 31, 2026