RENAISSANCE SYSTEM
Neurological Stereotaxic Instrument
MAZOR ROBOTICS LTD
The following data is part of a premarket notification filed by Mazor Robotics Ltd with the FDA for Renaissance System.
Pre-market Notification Details
| Device ID | K113228 |
| 510k Number | K113228 |
| Device Name: | RENAISSANCE SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MAZOR ROBOTICS LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein MAZOR ROBOTICS LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2011-12-01 |
| Summary: | summary |
Trademark Results [RENAISSANCE SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENAISSANCE SYSTEM 74547552 not registered Dead/Abandoned |
DE BRUIJN WILFORD, KAREN 1994-07-11 |
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