The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for Trigon Ha Wedge Fixation System.
| Device ID | K220197 |
| 510k Number | K220197 |
| Device Name: | Trigon HA Wedge Fixation System |
| Classification | Bone Wedge |
| 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 | PLF |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005669887 | K220197 | 000 |
| 00810005669870 | K220197 | 000 |
| 00810005669863 | K220197 | 000 |
| 00810005669856 | K220197 | 000 |
| 00810005669849 | K220197 | 000 |
| 00810005669832 | K220197 | 000 |
| 00814008029945 | K220197 | 000 |