The following data is part of a premarket notification filed by Axogen Corporation with the FDA for Axogen Nerve Cap.
| Device ID | K163446 |
| 510k Number | K163446 |
| Device Name: | AxoGen Nerve Cap |
| Classification | Cuff, Nerve |
| Applicant | AxoGen Corporation 13631 Progress Blvd Alachua, FL 32615 |
| Contact | Mark L. Friedman |
| Correspondent | Wendy Perreault New South Regulatory, LLC 223 Coventry Road Decatur, GA 30030 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-08-08 |
| Summary: | summary |