The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Cannulated Metallic Hemi Toe Implant, Models Mpj241975, Mpj221775, Mpj211675, Mpj191565, Mpj171365.
| Device ID | K023684 |
| 510k Number | K023684 |
| Device Name: | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | VILEX, INC. 345 OLD CURRY HOLLOW RD. Pleasant Hills, PA 15236 |
| Contact | Abraham Lavi |
| Correspondent | Abraham Lavi VILEX, INC. 345 OLD CURRY HOLLOW RD. Pleasant Hills, PA 15236 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2004-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731121820 | K023684 | 000 |
| 00841731106148 | K023684 | 000 |
| 00841731106162 | K023684 | 000 |
| 00841731106186 | K023684 | 000 |
| 00841731106209 | K023684 | 000 |
| 00841731106223 | K023684 | 000 |
| 00841731106247 | K023684 | 000 |
| 00841731106261 | K023684 | 000 |
| 00841731106285 | K023684 | 000 |
| 00841731106308 | K023684 | 000 |
| 00841731106377 | K023684 | 000 |
| 00841731106384 | K023684 | 000 |
| 00841731106391 | K023684 | 000 |
| 00841731106407 | K023684 | 000 |
| 00841731106414 | K023684 | 000 |
| 00841731114709 | K023684 | 000 |
| 00841731106124 | K023684 | 000 |