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 |