The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for Trigon Ha Stand-alone Wedge Fixation System.
| Device ID | K193414 |
| 510k Number | K193414 |
| Device Name: | Trigon HA Stand-Alone Wedge Fixation System |
| Classification | Bone Wedge |
| Applicant | Nvision Biomedical Technologies, Inc 4754 Shavano Oak, Suite 101 San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Jeffrey Brittan Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
| Product Code | PLF |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005668293 | K193414 | 000 |
| 00810005667890 | K193414 | 000 |
| 00810005667784 | K193414 | 000 |
| 00810005667777 | K193414 | 000 |
| 00810005667760 | K193414 | 000 |
| 00810005667753 | K193414 | 000 |
| 00810005667746 | K193414 | 000 |
| 00810005667739 | K193414 | 000 |
| 00810005667722 | K193414 | 000 |
| 00810005667715 | K193414 | 000 |
| 00810005667708 | K193414 | 000 |
| 00810005667692 | K193414 | 000 |
| 00810005667685 | K193414 | 000 |
| 00810005667906 | K193414 | 000 |
| 00810005667913 | K193414 | 000 |
| 00810005667920 | K193414 | 000 |
| 00810005668286 | K193414 | 000 |
| 00810005668279 | K193414 | 000 |
| 00810005668262 | K193414 | 000 |
| 00810005668255 | K193414 | 000 |
| 00810005668248 | K193414 | 000 |
| 00810005668231 | K193414 | 000 |
| 00810005668224 | K193414 | 000 |
| 00810005668217 | K193414 | 000 |
| 00810005668200 | K193414 | 000 |
| 00810005668194 | K193414 | 000 |
| 00810005667944 | K193414 | 000 |
| 00810005667937 | K193414 | 000 |
| 00810005667678 | K193414 | 000 |