Zenius™, Iliad™ And Kora™ Spinal Fixation Systems
Thoracolumbosacral Pedicle Screw System
Medyssey USA, Inc.
The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Zenius™, Iliad™ And Kora™ Spinal Fixation Systems.
Pre-market Notification Details
| Device ID | K181978 |
| 510k Number | K181978 |
| Device Name: | Zenius™, Iliad™ And Kora™ Spinal Fixation Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
| Contact | Shawn Kim |
| Correspondent | Margeaux Rogers Musculoskeletal Clinical Reulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-24 |
| Decision Date | 2018-08-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800042402853 | K181978 | 000 |
| 08800042402778 | K181978 | 000 |
| 08800042402761 | K181978 | 000 |
| 08800042402754 | K181978 | 000 |
| 08800042402747 | K181978 | 000 |
| 08800042402730 | K181978 | 000 |
| 08800042402723 | K181978 | 000 |
| 08800042402716 | K181978 | 000 |
| 08800042402709 | K181978 | 000 |
| 08800042402693 | K181978 | 000 |
| 08800042402686 | K181978 | 000 |
| 08800042402679 | K181978 | 000 |
| 08800042402662 | K181978 | 000 |
| 08800042402655 | K181978 | 000 |
| 08800042402648 | K181978 | 000 |
| 08800042402785 | K181978 | 000 |
| 08800042402792 | K181978 | 000 |
| 08800042402808 | K181978 | 000 |
| 08800042402846 | K181978 | 000 |
| 08800042402952 | K181978 | 000 |
| 08800042402945 | K181978 | 000 |
| 08800042402938 | K181978 | 000 |
| 08800042402921 | K181978 | 000 |
| 08800042402914 | K181978 | 000 |
| 08800042402907 | K181978 | 000 |
| 08800042402891 | K181978 | 000 |
| 08800042402884 | K181978 | 000 |
| 08800042402877 | K181978 | 000 |
| 08800042402860 | K181978 | 000 |
| 08800042402839 | K181978 | 000 |
| 08800042402822 | K181978 | 000 |
| 08800042402815 | K181978 | 000 |
| 08800042402631 | K181978 | 000 |
Trademark Results [Zenius]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENIUS 88479733 not registered Live/Pending |
BJ Trading LLC 2019-06-19 |
 ZENIUS 85197584 4368966 Live/Registered |
Societe des Produits Nestle S.A. 2010-12-14 |
 ZENIUS 79099954 4107390 Live/Registered |
EVOLIS 2011-04-21 |
 ZENIUS 78529195 3408975 Dead/Cancelled |
Ares Trading S.A. 2004-12-08 |
 ZENIUS 77340920 not registered Dead/Abandoned |
Sahajanand Biotech, Inc 2007-11-30 |
 ZENIUS 75940489 2526012 Dead/Cancelled |
Computer Task Group, Inc. 2000-02-22 |
 ZENIUS 75875241 2520996 Dead/Cancelled |
Computer Task Group, Inc. 1999-12-29 |
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