K161370 is an FDA 510(k) clearance for the Durepair Dura Regeneration Matrix. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on November 2, 2016, 169 days after receiving the submission on May 17, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K161370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2016 |
| Decision Date | November 02, 2016 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |