Identity
- Trade Name
- Mazor X Navigation Camera FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Model / Reference
- TPL0063-07 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115752755 FDA UDI
- 510(k) Number
- K230064 FDA UDI
- FDA Product Code
- OLO FDA UDILLZ FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose stereotactic surgery system
Mazor X Navigation Camera by Mazor Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose stereotactic surgery system.
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- TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
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- Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
- NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
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 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 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 |
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Manufacturer
- Manufacturer
- Mazor Robotics Ltd
Sources (1)
- FDA UDI 487194cd-ebc9-49b9-ad21-bc58ca7a99d7 33 fields · synced Jun 8, 2026