The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Hemi Implant; Mini Hemi Implant.
| Device ID | K102401 |
| 510k Number | K102401 |
| Device Name: | HEMI IMPLANT; MINI HEMI IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | VILEX, INC. 111 MOFFITT STREET Mcminnville, TN 37110 |
| Contact | Sylvia Southard |
| Correspondent | Sylvia Southard VILEX, 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 | 2010-08-24 |
| Decision Date | 2011-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731106315 | K102401 | 000 |
| 00841731106155 | K102401 | 000 |
| 00841731106179 | K102401 | 000 |
| 00841731106193 | K102401 | 000 |
| 00841731106216 | K102401 | 000 |
| 00841731106230 | K102401 | 000 |
| 00841731106254 | K102401 | 000 |
| 00841731106278 | K102401 | 000 |
| 00841731106292 | K102401 | 000 |
| 00841731106131 | K102401 | 000 |