K183325 is an FDA 510(k) clearance for the Modus Nav. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on July 14, 2019, 226 days after receiving the submission on November 30, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K183325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2018 |
| Decision Date | July 14, 2019 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |