The following data is part of a premarket notification filed by Mazor Robotics Ltd with the FDA for Renaissance X System.
| Device ID | K140167 |
| 510k Number | K140167 |
| Device Name: | RENAISSANCE X SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAZOR ROBOTICS LTD 20 HATA'AS ST. (POB 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein MAZOR ROBOTICS LTD 20 HATA'AS ST. (POB 124) 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 | 2014-01-23 |
| Decision Date | 2014-09-10 |
| Summary: | summary |