The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Neuragen 3d Nerve Guide Matrix.
| Device ID | K163457 |
| 510k Number | K163457 |
| Device Name: | NeuraGen 3D Nerve Guide Matrix |
| Classification | Cuff, Nerve |
| Applicant | Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Contact | Gabriella Green |
| Correspondent | Gabriella Green Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780266846 | K163457 | 000 |
| 10381780266716 | K163457 | 000 |
| 10381780266730 | K163457 | 000 |
| 10381780266747 | K163457 | 000 |
| 10381780266754 | K163457 | 000 |
| 10381780266761 | K163457 | 000 |
| 10381780266778 | K163457 | 000 |
| 10381780266785 | K163457 | 000 |
| 10381780266792 | K163457 | 000 |
| 10381780266808 | K163457 | 000 |
| 10381780266815 | K163457 | 000 |
| 10381780266822 | K163457 | 000 |
| 10381780266839 | K163457 | 000 |
| 10381780266709 | K163457 | 000 |