Modus Nav
Neurological Stereotaxic Instrument
Synaptive Medical Inc.
The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Modus Nav.
Pre-market Notification Details
| Device ID | K183325 |
| 510k Number | K183325 |
| Device Name: | Modus Nav |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Synaptive Medical Inc. 555 Richmond Street West, Suite 800 Toronto, CA M5v 3b1 |
| Contact | Maham Ansari |
| Correspondent | Maham Ansari Synaptive Medical Inc. 555 Richmond Street West, Suite 800 Toronto, CA M5v 3b1 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000627 | K183325 | 000 |
| 00670082000535 | K183325 | 000 |
| 00670082000528 | K183325 | 000 |
| 00670082000504 | K183325 | 000 |
| 00670082000351 | K183325 | 000 |
| 00670082000269 | K183325 | 000 |
| 00670082000252 | K183325 | 000 |
Trademark Results [Modus Nav]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MODUS NAV 97882743 not registered Live/Pending |
SYNAPTIVE MEDICAL INC. 2023-04-11 |
 MODUS NAV 87597919 not registered Live/Pending |
SYNAPTIVE MEDICAL (BARBADOS) INC. 2017-09-06 |
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