The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Talus Of Vilex (tov).
| Device ID | K041289 |
| 510k Number | K041289 |
| Device Name: | TALUS OF VILEX (TOV) |
| Classification | Screw, Fixation, Bone |
| Applicant | VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh, PA 15236 |
| Contact | Abraham Lavi |
| Correspondent | Abraham Lavi VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh, PA 15236 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-13 |
| Decision Date | 2004-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731114693 | K041289 | 000 |
| 00841731106568 | K041289 | 000 |
| 00841731106551 | K041289 | 000 |
| 00841731106544 | K041289 | 000 |
| 00841731106537 | K041289 | 000 |
| 00841731106520 | K041289 | 000 |
| 00841731106513 | K041289 | 000 |
| 00841731106506 | K041289 | 000 |
| 00841731106490 | K041289 | 000 |
| 00841731106483 | K041289 | 000 |
| 00841731106575 | K041289 | 000 |
| 00841731106582 | K041289 | 000 |
| 00841731106599 | K041289 | 000 |
| 00841731114686 | K041289 | 000 |
| 00841731114679 | K041289 | 000 |
| 00841731114662 | K041289 | 000 |
| 00841731112835 | K041289 | 000 |
| 00841731106643 | K041289 | 000 |
| 00841731106636 | K041289 | 000 |
| 00841731106629 | K041289 | 000 |
| 00841731106612 | K041289 | 000 |
| 00841731106605 | K041289 | 000 |
| 00841731106476 | K041289 | 000 |