K113228 is an FDA 510(k) clearance for the RENAISSANCE SYSTEM. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Mazor Robotics , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on December 1, 2011, 30 days after receiving the submission on November 1, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K113228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | December 01, 2011 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |