The following data is part of a premarket notification filed by Vilex In Tennessee, Inc. with the FDA for Ezfuze Implant System.
| Device ID | K150211 |
| 510k Number | K150211 |
| Device Name: | EzFuze Implant System |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-11-10 |
| Summary: | summary |