The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Expressbraid Graft Manipulation.
| Device ID | K163651 |
| 510k Number | K163651 |
| Device Name: | ExpressBraid Graft Manipulation |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 |
| Contact | Vinay Bhal |
| Correspondent | Vinay Bhal Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-02-17 |
| Summary: | summary |