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 |