The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc. with the FDA for Nvc.
| Device ID | K190380 |
| 510k Number | K190380 |
| Device Name: | Nvc |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Nvision Biomedical Technologies, Inc. 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-03-21 |
| Summary: | summary |