The following data is part of a premarket notification filed by Acera Surgical, Inc. with the FDA for Cerafix Dura Substitute.
| Device ID | K161278 |
| 510k Number | K161278 |
| Device Name: | Cerafix Dura Substitute |
| Classification | Dura Substitute |
| Applicant | ACERA SURGICAL, INC. 10880 BAUR BLVD. St. Louis, MO 63132 |
| Contact | Matthew Macewan |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY Suite 120 Woodstock, GA 30188 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2016-08-08 |
| Summary: | summary |