The following data is part of a premarket notification filed by Vilex In Tennessee, Inc. with the FDA for Cannulated Hemi Implant.
| Device ID | K190543 |
| 510k Number | K190543 |
| Device Name: | Cannulated Hemi Implant |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | Vilex In Tennessee, Inc. 111 Moffitt Street Mcminnville, TN 37110 |
| Contact | Sylvia Southard |
| Correspondent | Victor Lavi Vilex In Tennessee, Inc. 111 Moffitt Street Mcminnville, TN 37110 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-05-31 |