The following data is part of a premarket notification filed by Neurovention Llc with the FDA for Neurovention Cranial Fixation System, Nucrani Plates, Ktc Burr Hole Cover, Dc Plate.
| Device ID | K192162 |
| 510k Number | K192162 |
| Device Name: | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate |
| Classification | Cover, Burr Hole |
| Applicant | NeuroVention LLC 645 S. Beach St. Daytona Beach, FL 32114 |
| Contact | Rohit Khanna |
| Correspondent | Rohit Khanna NeuroVention LLC 645 S. Beach St. Daytona Beach, FL 32114 |
| Product Code | GXR |
| Subsequent Product Code | GWO |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G28441001 | K192162 | 000 |
| G28440901 | K192162 | 000 |
| G28436102 | K192162 | 000 |
| G28435201 | K192162 | 000 |
| G28435101 | K192162 | 000 |
| G28433001 | K192162 | 000 |
| G28424101 | K192162 | 000 |
| G284241019 | K192162 | 000 |