The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Modification To Durepair Dura Regeneration Matrix.
| Device ID | K063117 |
| 510k Number | K063117 |
| Device Name: | MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX |
| Classification | Dura Substitute |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffery Henderson |
| Correspondent | Jeffery Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-12 |
| Decision Date | 2006-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169063907 | K063117 | 000 |
| 00643169063891 | K063117 | 000 |
| 00643169063884 | K063117 | 000 |
| 00643169063877 | K063117 | 000 |
| 00643169063860 | K063117 | 000 |
| 00643169063853 | K063117 | 000 |