The following data is part of a premarket notification filed by Nanovis Llc with the FDA for Nano Forticore, Forticore.
| Device ID | K191822 |
| 510k Number | K191822 |
| Device Name: | Nano FortiCore, FortiCore |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Nanovis LLC 5865 East State Rd. 14 Columbia City, IN 46725 |
| Contact | Matthew Hedrick |
| Correspondent | Karen E Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-08 |
| Decision Date | 2019-10-11 |
| Summary: | summary |