The following data is part of a premarket notification filed by Acera Surgical, Inc. with the FDA for Cerafix Dura Substitute.
| Device ID | K172603 |
| 510k Number | K172603 |
| 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 | 2017-08-30 |
| Decision Date | 2017-11-27 |
| Summary: | summary |