The following data is part of a premarket notification filed by Mazor Robotics Ltd. with the FDA for Mazor X System (mazor X Stealth Edition).
| Device ID | K182077 |
| 510k Number | K182077 |
| Device Name: | Mazor X System (Mazor X Stealth Edition) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea, IL 3088900 |
| Contact | Marina Hefetz |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-11-02 |
| Summary: | summary |