The following data is part of a premarket notification filed by Vilex In Tennessee, Inc. with the FDA for Trident Fusion Implant.
| Device ID | K141937 |
| 510k Number | K141937 |
| Device Name: | TRIDENT FUSION IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | VILEX IN TENNESSEE, INC. 8374 MARKET STREET, #167 Lakewood Ranch, FL 34202 |
| Contact | Abraham Lavi |
| Correspondent | Abraham Lavi VILEX IN TENNESSEE, 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 | 2014-07-17 |
| Decision Date | 2014-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731114716 | K141937 | 000 |
| 00841731106889 | K141937 | 000 |
| 00841731106872 | K141937 | 000 |
| 00841731106865 | K141937 | 000 |
| 00841731106858 | K141937 | 000 |
| 00841731106841 | K141937 | 000 |
| 00841731106834 | K141937 | 000 |