The following data is part of a premarket notification filed by Nanovis Llc with the FDA for Forticore®.
| Device ID | K171312 |
| 510k Number | K171312 |
| Device Name: | FortiCore® |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Nanovis LLC 5865 East State Rd. 14 Columbia City, IN 46725 |
| Contact | Matthew Hedrick |
| Correspondent | Karen E. Warden BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-04 |
| Decision Date | 2018-01-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FORTICORE 88191764 not registered Live/Pending |
Incipio, LLC 2018-11-13 |
![]() FORTICORE 86428545 5008687 Live/Registered |
FORTINET, INC. 2014-10-20 |
![]() FORTICORE 85740388 4660083 Live/Registered |
Nanovis, LLC 2012-09-27 |