The following data is part of a premarket notification filed by Nanovis, Llc with the FDA for Nanovis Spinal System.
| Device ID | K113173 |
| 510k Number | K113173 |
| Device Name: | NANOVIS SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | NANOVIS, LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden Phd. |
| Correspondent | Karen E Warden Phd. NANOVIS, LLC 8202 SHERMAN RD. Chesterland, OH 44026 -2141 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-27 |
| Decision Date | 2012-01-19 |
| Summary: | summary |