The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Nvc.
| Device ID | K170074 |
| 510k Number | K170074 |
| Device Name: | Nvc |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103 San Antonio, TX 78232 |
| Contact | Diana L Langham |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-01-24 |
| Summary: | summary |