K161278 is an FDA 510(k) clearance for the Cerafix Dura Substitute. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 8, 2016, 94 days after receiving the submission on May 6, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K161278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2016 |
| Decision Date | August 08, 2016 |
| Days to Decision | 94 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 |