Mazor X
Orthopedic Stereotaxic Instrument
Mazor Robotics Ltd.
The following data is part of a premarket notification filed by Mazor Robotics Ltd. with the FDA for Mazor X.
Pre-market Notification Details
| Device ID | K180307 |
| 510k Number | K180307 |
| Device Name: | Mazor X |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea, IL 3088900 |
| Contact | Shiran Conforti |
| Correspondent | Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. Kfar Saba, IL 44425 |
| Product Code | OLO |
| Subsequent Product Code | HAW |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-04-30 |
| Summary: | summary |
Trademark Results [Mazor X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAZOR X 88839993 not registered Live/Pending |
Mazor Robotics Ltd. 2020-03-19 |
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