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 |