The following data is part of a premarket notification filed by Vilex In Tennessee, Inc with the FDA for Small Bone Nail Implant.
| Device ID | K151456 |
| 510k Number | K151456 |
| Device Name: | Small Bone Nail Implant |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731122032 | K151456 | 000 |
| 00841731119483 | K151456 | 000 |
| 00841731119476 | K151456 | 000 |
| 00841731119469 | K151456 | 000 |
| 00841731119452 | K151456 | 000 |
| 00841731119445 | K151456 | 000 |
| 00841731119438 | K151456 | 000 |
| 00841731119421 | K151456 | 000 |
| 00841731119414 | K151456 | 000 |
| 00841731119407 | K151456 | 000 |
| 00841731119391 | K151456 | 000 |
| 00841731119384 | K151456 | 000 |
| 00841731119377 | K151456 | 000 |
| 00841731123299 | K151456 | 000 |
| 00841731123282 | K151456 | 000 |
| 00841731129987 | K151456 | 000 |
| 00841731136527 | K151456 | 000 |
| 00841731119490 | K151456 | 000 |
| 00841731119506 | K151456 | 000 |
| 00841731119513 | K151456 | 000 |
| 00841731122025 | K151456 | 000 |
| 00841731122018 | K151456 | 000 |
| 00841731122001 | K151456 | 000 |
| 00841731121998 | K151456 | 000 |
| 00841731121981 | K151456 | 000 |
| 00841731121974 | K151456 | 000 |
| 00841731121967 | K151456 | 000 |
| 00841731121950 | K151456 | 000 |
| 00841731119599 | K151456 | 000 |
| 00841731119582 | K151456 | 000 |
| 00841731119575 | K151456 | 000 |
| 00841731119568 | K151456 | 000 |
| 00841731119551 | K151456 | 000 |
| 00841731119544 | K151456 | 000 |
| 00841731119537 | K151456 | 000 |
| 00841731119520 | K151456 | 000 |
| 00841731136367 | K151456 | 000 |