The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Fuze: Intramedullary Internal Fixation Nail.
| Device ID | K102413 |
| 510k Number | K102413 |
| Device Name: | FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | VILEX, INC. 111 MOFFITT STREET Mcminnville, TN 37110 |
| Contact | Abe Lavi |
| Correspondent | Abe Lavi VILEX, INC. 111 MOFFITT STREET Mcminnville, TN 37110 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-24 |
| Decision Date | 2011-11-14 |
| Summary: | summary |