The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex Ultima External Fixation System With Ha Coated Pins And Wires.
| Device ID | K132820 |
| 510k Number | K132820 |
| Device Name: | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES |
| Classification | Pin, Fixation, Threaded |
| Applicant | VILEX, INC. 7214 LAKE FOREST GLEN Lakewood Ranch, FL 34202 |
| Contact | Abraham Lavi |
| Correspondent | Abraham Lavi VILEX, INC. 7214 LAKE FOREST GLEN Lakewood Ranch, FL 34202 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-07-23 |
| Summary: | summary |