The following data is part of a premarket notification filed by Vilex In Tennessee, Inc with the FDA for Ultima Ha Coated Half Pins And Wire.
| Device ID | K163487 |
| 510k Number | K163487 |
| Device Name: | Ultima HA Coated Half Pins And Wire |
| Classification | Pin, Fixation, Threaded |
| Applicant | Vilex In Tennessee, Inc 111 Moffitt Street Mcminnville, TN 37110 |
| Contact | Sylvia Southard |
| Correspondent | Abraham Lavi Vilex, Inc. 8374 Market Street, #167 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 | 2016-12-12 |
| Decision Date | 2017-02-13 |
| Summary: | summary |