The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Modus Nav.
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 |
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 |