The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for The Radian Mis Bunion System.
| Device ID | K211650 |
| 510k Number | K211650 |
| Device Name: | The Radian MIS Bunion 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 | 2021-05-28 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005665704 | K211650 | 000 |
| 00810005669344 | K211650 | 000 |