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 |