The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc with the FDA for Vector Hammertoe Correction System.
| Device ID | K201850 |
| 510k Number | K201850 |
| Device Name: | Vector Hammertoe Correction System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Analaura Villarreal Berain Nvision Biomedical Technologies, Inc 4590 Lockhill Selma San Antonio, TX 78249 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2020-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005667791 | K201850 | 000 |
| 00810005660921 | K201850 | 000 |
| 00810005660938 | K201850 | 000 |
| 00810005660945 | K201850 | 000 |
| 00810005660952 | K201850 | 000 |
| 00810005660969 | K201850 | 000 |
| 00810005660976 | K201850 | 000 |
| 00810005660983 | K201850 | 000 |
| 00810005660990 | K201850 | 000 |
| 00810005668477 | K201850 | 000 |