The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex X-fix.
| Device ID | K052196 |
| 510k Number | K052196 |
| Device Name: | VILEX X-FIX |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-11-22 |
| Summary: | summary |