The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex Bone Plate System.
| Device ID | K041287 |
| 510k Number | K041287 |
| Device Name: | VILEX BONE PLATE SYSTEM |
| 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 |