The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Medyssy Lt Cage System.
| Device ID | K121246 |
| 510k Number | K121246 |
| Device Name: | MEDYSSY LT CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE Skokie, IL 60077 |
| Contact | Michael Kvitnisky |
| Correspondent | Michael Kvitnisky MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE Skokie, IL 60077 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-25 |
| Decision Date | 2012-06-15 |
| Summary: | summary |