The following data is part of a premarket notification filed by Nanovis Spine Llc with the FDA for Nano Fortifix® System.
| Device ID | K193211 |
| 510k Number | K193211 |
| Device Name: | Nano FortiFix® System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Nanovis Spine 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2020-03-20 |