The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Durepair Dura Regeneration Matrix.
| Device ID | K161370 |
| 510k Number | K161370 |
| Device Name: | Durepair Dura Regeneration Matrix |
| Classification | Dura Substitute |
| Applicant | Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117 |
| Contact | Manas Lele |
| Correspondent | Manas Lele Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-17 |
| Decision Date | 2016-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780540892 | K161370 | 000 |
| 10381780540878 | K161370 | 000 |
| 10381780540854 | K161370 | 000 |
| 00643169063884 | K161370 | 000 |
| 10381780540786 | K161370 | 000 |
| 00643169063877 | K161370 | 000 |