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 |