The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for Javelin Tailor's Bunion Fixation System.
| Device ID | K202657 |
| 510k Number | K202657 |
| Device Name: | Javelin Tailor's Bunion Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Analaura Villarreal-berain Nvision Biomedical Technologies 4590 Lockhill Selma San Antonio, TX 78249 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2020-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005665698 | K202657 | 000 |
| 00810005665551 | K202657 | 000 |
| 00810005665544 | K202657 | 000 |
| 00810005665537 | K202657 | 000 |
| 00810005665520 | K202657 | 000 |
| 00810005665421 | K202657 | 000 |
| 00810005665414 | K202657 | 000 |
| 00810005665407 | K202657 | 000 |
| 00810005665391 | K202657 | 000 |
| 00810005665384 | K202657 | 000 |
| 00810005665377 | K202657 | 000 |
| 00810005665360 | K202657 | 000 |
| 00810005665568 | K202657 | 000 |
| 00810005665575 | K202657 | 000 |
| 00810005665681 | K202657 | 000 |
| 00810005665674 | K202657 | 000 |
| 00810005665667 | K202657 | 000 |
| 00810005665650 | K202657 | 000 |
| 00810005665643 | K202657 | 000 |
| 00810005665636 | K202657 | 000 |
| 00810005665629 | K202657 | 000 |
| 00810005665612 | K202657 | 000 |
| 00810005665605 | K202657 | 000 |
| 00810005665599 | K202657 | 000 |
| 00810005665582 | K202657 | 000 |
| 00810005665353 | K202657 | 000 |