The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Medussa-pl Cage.
Device ID | K170341 |
510k Number | K170341 |
Device Name: | Medussa-PL Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Medyssey USA, Inc. 1550 East Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
Contact | Shawn Kim |
Correspondent | Cheryl L. Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-03 |
Decision Date | 2017-11-02 |
Summary: | summary |