The following data is part of a premarket notification filed by Nanovis Llc with the FDA for Nanovis Intervertebral Body Fusion System And Forticore®.
| Device ID | K160874 |
| 510k Number | K160874 |
| Device Name: | Nanovis Intervertebral Body Fusion System And FortiCore® |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NANOVIS LLC 5865 E STATE RD. 14 Columbia City, IN 46725 |
| Contact | Matthew Hedrick |
| Correspondent | Karen E. Warden BACKROADS CONSULTING INC. PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-06-28 |
| Summary: | summary |