The following data is part of a premarket notification filed by Mazor Robotics Ltd. with the FDA for Renaissance X System.
| Device ID | K152041 |
| 510k Number | K152041 |
| Device Name: | Renaissance X System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Mazor Robotics Ltd. PO Box 3104, 7 HaEshel St. Caesarea Park South, IL 3088900 |
| Contact | Ayelet Matia |
| Correspondent | Moshe Rosenberg A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as St. (POB 124) Kfar Saba, IL 4442520 |
| 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 | 2015-07-22 |
| Decision Date | 2015-11-17 |
| Summary: | summary |