The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Athena Ii Cervical Plate System.
Device ID | K183409 |
510k Number | K183409 |
Device Name: | Athena II Cervical Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
Contact | Shawn Kim |
Correspondent | Rich Jansen Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, FL 33905 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-10 |
Decision Date | 2019-02-11 |
Summary: | summary |