The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Iliad Pedicle Screw System And Zenius Pedicle Screw System.
| Device ID | K142835 |
| 510k Number | K142835 |
| Device Name: | Iliad Pedicle Screw System And Zenius Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, SUITE 123 Elk Grove Village, IL 60007 |
| Contact | John Kuczynski |
| Correspondent | Rich Jansen SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Fort Myers, FL 33905 |
| 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 | 2014-09-30 |
| Decision Date | 2015-06-12 |
| Summary: | summary |