The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Zenius Spinal System.
| Device ID | K170964 |
| 510k Number | K170964 |
| Device Name: | Zenius Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medyssey USA, Inc. 1550 East Higgins Road Suite 123 Elk Grove Village, IL 60007 |
| Contact | Shawn Kim |
| Correspondent | Christine Scifert, Ms, Mem MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-04-26 |
| Summary: | summary |