The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Vilex Ez-staple (memory Bone Fixation Staple).
| Device ID | K112837 |
| 510k Number | K112837 |
| Device Name: | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) |
| Classification | Staple, Fixation, Bone |
| Applicant | VILEX, INC. 111 MOFFITT STREET Mcminnville, TN 37110 |
| Contact | Sylvia Southard |
| Correspondent | Sylvia Southard VILEX, INC. 111 MOFFITT STREET Mcminnville, TN 37110 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731120212 | K112837 | 000 |
| 00841731106759 | K112837 | 000 |
| 00841731106742 | K112837 | 000 |
| 00841731106735 | K112837 | 000 |
| 00841731106728 | K112837 | 000 |
| 00841731106711 | K112837 | 000 |
| 00841731106704 | K112837 | 000 |
| 00841731106698 | K112837 | 000 |
| 00841731106681 | K112837 | 000 |
| 00841731106674 | K112837 | 000 |
| 00841731106667 | K112837 | 000 |
| 00841731106766 | K112837 | 000 |
| 00841731106773 | K112837 | 000 |
| 00841731120045 | K112837 | 000 |
| 00841731120038 | K112837 | 000 |
| 00841731119216 | K112837 | 000 |
| 00841731115089 | K112837 | 000 |
| 00841731115072 | K112837 | 000 |
| 00841731106827 | K112837 | 000 |
| 00841731106810 | K112837 | 000 |
| 00841731106803 | K112837 | 000 |
| 00841731106797 | K112837 | 000 |
| 00841731106780 | K112837 | 000 |
| 00841731106650 | K112837 | 000 |