The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Lliad, Kora, Zenius Pedicle Screw System.
| Device ID | K131878 |
| 510k Number | K131878 |
| Device Name: | LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDYSSEY USA, INC. 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen MEDYSSEY USA, INC. 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | NKB |
| 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 | 2013-06-24 |
| Decision Date | 2013-08-23 |
| Summary: | summary |