NeuroShield
Cuff, Nerve
Monarch Bioimplants GmbH
The following data is part of a premarket notification filed by Monarch Bioimplants Gmbh with the FDA for Neuroshield.
Pre-market Notification Details
| Device ID | K190246 |
| 510k Number | K190246 |
| Device Name: | NeuroShield |
| Classification | Cuff, Nerve |
| Applicant | Monarch Bioimplants GmbH Platz 4 Root, CH 6039 |
| Contact | Rivelino Montenegro |
| Correspondent | Rivelino Montenegro Monarch Bioimplants GmbH Platz 4 Root, CH 6039 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-05-31 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640181710201 | K190246 | 000 |
| 07640181711208 | K190246 | 000 |
| B130PV40301 | K190246 | 000 |
| B130NS40300 | K190246 | 000 |
| B130NS30201 | K190246 | 000 |
Trademark Results [NeuroShield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROSHIELD 97257392 not registered Live/Pending |
Midlink LLC 2022-02-08 |
 NEUROSHIELD 87602401 not registered Dead/Abandoned |
In-Med Prognostics L3C 2017-09-10 |
 NEUROSHIELD 87117681 not registered Dead/Abandoned |
BAUER INNOVATIONS US, LLC 2016-07-27 |
 NEUROSHIELD 85324932 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2011-05-19 |
 NEUROSHIELD 79259021 not registered Dead/Abandoned |
SENESCENCE LIFE SCIENCES PTE. LTD. 2019-01-15 |
 NEUROSHIELD 79241162 5917168 Live/Registered |
Monarch Bioimplants GmbH 2018-06-18 |
 NEUROSHIELD 79222791 5582909 Live/Registered |
Monarch Bioimplants GmbH 2017-09-19 |
 NEUROSHIELD 77344742 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2007-12-05 |
 NEUROSHIELD 75389682 2803862 Dead/Cancelled |
Mednova Limited 1997-11-13 |
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