The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Nvc.
| Device ID | K142328 |
| 510k Number | K142328 |
| Device Name: | Nvc |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NVISION BIOMEDICAL TECHNOLOGIES, LLC 18618 TUSCANY STONE SUITE 120 San Antonio, TN 78258 |
| Contact | Brian Kieser |
| Correspondent | Jennifer Palinchik JALEX MEDICAL, LLC 27881 CLEMENS ROAD SUITE 2 Westlake, OH 44145 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-20 |
| Decision Date | 2014-12-23 |
| Summary: | summary |