The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Medussa-pl Cage.
| Device ID | K200283 |
| 510k Number | K200283 |
| Device Name: | Medussa-PL Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 |
| Contact | Shawn Kim |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-06-18 |