The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Vector Hammertoe Correction System.
| Device ID | K183055 |
| 510k Number | K183055 |
| Device Name: | Vector Hammertoe Correction System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nvision Biomedical Technologies, LLC 4754 Shavano Oak, Suite 101 San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Jeffrey Brittan Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810005666763 | K183055 | 000 |
| 00810005666756 | K183055 | 000 |
| 00810005666749 | K183055 | 000 |
| 00810005666732 | K183055 | 000 |
| 00810005666725 | K183055 | 000 |
| 00810005666718 | K183055 | 000 |