The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Win Flexible Nail System.
| Device ID | K193533 |
| 510k Number | K193533 |
| Device Name: | WIN Flexible Nail System |
| Classification | Pin, Fixation, Smooth |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Contact | Dominique Dompor |
| Correspondent | Dominique Dompor Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-02-20 |